Regulatory timeline
476 dated events across 168 products, including 345 approvals, plus designations, filings, complete response letters, withdrawals, and label changes. Sort by date, filter by type or region, and click through to the product.
476 events
| Event | Region | What happened | ||
|---|---|---|---|---|
| 14 Nov 2026 | Ivonescimab Bispecific antibody (PD-1×VEGF) | PDUFA date | US | PDUFA target date source |
| 23 Sept 2026 | Galleri Multi-cancer early detection blood test | Advisory committee | US | FDA Molecular and Clinical Genetics Panel meeting source |
| 4 Sept 2026 | Camizestrant Oral SERD | Approval | US | Accelerated approval (Etcamah) source |
| 28 Aug 2026 | 177Lu-edotreotide Radioligand therapy (beta) | PDUFA date | US | PDUFA goal date for GEP-NET indication source |
| 19 Aug 2026 | Intismeran autogene Personalised mRNA neoantigen vaccine | Filing / deal | US | Phase 3 INTerpath-001 met RFS and DMFS endpoints; filings to follow source |
| 6 Aug 2026 | Vusolimogene oderparepvec Oncolytic virus (HSV-1) | Approval | US | Accelerated approval with nivolumab for unresectable/metastatic melanoma after anti-PD-1 (IGNYTE) source |
| 31 Jul 2026 | Lutetium-177 vipivotide tetraxetan Radioligand therapy (beta) | Approval | US | PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition) source |
| 30 Jul 2026 | Selinexor Small-molecule XPO1 (nuclear export) inhibitor | Filing / deal | US | XPORT-EC-042 misses primary endpoint; endometrial development deprioritised source |
| 23 Jul 2026 | Camrelizumab + rivoceranib PD-1 antibody + oral VEGFR2 inhibitor | Complete response letter | US | Third CRL, again cGMP source |
| Jul 2026 | Gedatolisib Small-molecule pan-PI3K/mTOR inhibitor | Approval | US | HR+/HER2- advanced breast cancer after CDK4/6 inhibitor with palbociclib and fulvestrant (VIKTORIA-1) source |
| Jul 2026 | Isatuximab Monoclonal antibody (anti-CD38) | Approval | US | Subcutaneous on-body injector |
| Jul 2026 | Designation | US | Commissioner's National Priority Voucher (CNPV) awarded source | |
| Jul 2026 | Selpercatinib Small-molecule kinase inhibitor (RET) | Label change | US | Label update (July 2026 oncology approvals list) source |
| Jul 2026 | Zidesamtinib Small-molecule kinase inhibitor (ROS1) | Approval | US | ROS1+ NSCLC (ARROS-1) source |
| 2026 | Cretostimogene grenadenorepvec Oncolytic adenovirus (intravesical) | Filing / deal | US | Rolling BLA initiated; completion expected Q4 2026 source |
| 2026 | Fianlimab Monoclonal antibody (anti-LAG-3) | Designation | US | First-line metastatic phase 3 missed its primary PFS endpoint (Regeneron release) |
| Q2 2026 | Afamitresgene autoleucel TCR-T (MAGE-A4) | Label change | US | Label extended to patients aged 12 and older source |
| May 2026 | ArteraAI Breast AI digital pathology risk test | Approval | US | FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer source |
| Q2 2026 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Adjuvant ctDNA-positive muscle-invasive bladder cancer (IMvigor011): first ctDNA-guided indication source |
| Q2 2026 | Belzutifan Small-molecule HIF-2α inhibitor | Approval | US | Adjuvant clear-cell RCC with pembrolizumab (LITESPARK-022) source |
| Q2 2026 | Capivasertib Small-molecule AKT inhibitor | Approval | US | PTEN-deficient metastatic prostate cancer with abiraterone (CAPItello-281) source |
| Q2 2026 | Approval | US | First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible (TROPION-Breast02) source | |
| Q2 2026 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC) source |
| Q2 2026 | Palbociclib Small-molecule CDK4/6 inhibitor | Approval | US | Maintenance in HR+/HER2+ advanced breast cancer with anti-HER2 and endocrine therapy (PATINA) source |
| Q2 2026 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | Adjuvant RCC with belzutifan; with sacituzumab govitecan in first-line PD-L1+ TNBC source |
| Q2 2026 | Approval | US | First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04) source | |
| Q2 2026 | Signatera Tumour-informed ctDNA MRD test | Label change | US | Used to select ctDNA-positive patients in the first ctDNA-guided drug approval (IMvigor011, atezolizumab) source |
| Q2 2026 | Approval | US | Early-stage HER2+ breast cancer: neoadjuvant (DESTINY-Breast11) and post-neoadjuvant residual disease (DESTINY-Breast05) source | |
| Q2 2026 | Label change | US | Displaced post-neoadjuvantly by T-DXd approval (DESTINY-Breast05) source | |
| Q2 2026 | Vepdegestrant PROTAC oestrogen receptor degrader | Approval | US | ESR1-mutated ER+/HER2- advanced breast cancer after endocrine therapy: first PROTAC approved source |
| Q2 2026 | Zenocutuzumab Bispecific antibody (HER2×HER3) | Approval | US | NRG1-fusion cholangiocarcinoma source |
| 13 May 2026 | Decitabine + cedazuridine (oral) Oral hypomethylating agent | Approval | US | With venetoclax in newly diagnosed unfit AML source |
| 13 May 2026 | Sonrotoclax Small-molecule BCL-2 inhibitor (second generation) | Approval | US | Accelerated approval in MCL; priority review, Project Orbis source |
| 30 Apr 2026 | Camizestrant Oral SERD | Advisory committee | US | ODAC voted 6-3 against (clinical relevance of ctDNA-triggered switch) source |
| Mar 2026 | Nivolumab Monoclonal antibody (anti-PD-1) | Approval | US | First-line advanced classical Hodgkin lymphoma with AVD, age ≥12 (SWOG S1826) source |
| Mar 2026 | Tafasitamab Monoclonal antibody (anti-CD19, Fc-enhanced) | Filing / deal | US | sBLA for frontline high-risk DLBCL (frontMIND) planned H1 2026 source |
| Mar 2026 | Tazemetostat Small-molecule EZH2 inhibitor | Withdrawal | Global | Withdrawn over secondary haematologic malignancies |
| Mar 2026 | Zelenectide pevedotin Bicycle toxin conjugate (Nectin-4, MMAE) | Withdrawal | US | Programme deprioritised after regulatory feedback on Duravelo-2 design source |
| 9 Mar 2026 | Giredestrant Oral SERD | Designation | Global | persevERA primary endpoint not met source |
| 9 Mar 2026 | Piflufolastat F-18 / Pylarify TruVu PET imaging agent | Approval | US | Pylarify TruVu formulation source |
| 5 Mar 2026 | Daratumumab Monoclonal antibody (anti-CD38) | Approval | US | Teclistamab + daratumumab after ≥1 prior line source |
| 26 Feb 2026 | Izalontamab brengitecan Bispecific ADC | Filing / deal | China | Positive interim phase 3 in pretreated TNBC (BL-B01D1-307) announced; regulatory submissions follow source |
| 19 Feb 2026 | Acalabrutinib Small-molecule covalent BTK inhibitor (second generation) | Approval | US | Acalabrutinib + venetoclax fixed duration (AMPLIFY) source |
| 19 Feb 2026 | Giredestrant Oral SERD | Filing / deal | US | NDA accepted (evERA, ESR1-mutant) source |
| Feb 2026 | Anitocabtagene autoleucel CAR-T (BCMA, D-domain binder) | Filing / deal | US | BLA accepted; PDUFA 27 December 2026 source |
| Feb 2026 | Atirmociclib Small-molecule CDK4-selective inhibitor | Designation | Global | Positive topline phase 2 FOURLIGHT-1 source |
| Q1 2026 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | Full approval in first-line BRAF V600E mCRC with OS benefit source |
| Q1 2026 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | Optune Pax, locally advanced pancreatic cancer with chemotherapy (PANOVA-3) source |
| Q1 2026 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | Platinum-resistant PD-L1+ ovarian cancer source |
| Q1 2026 | Relacorilant Small-molecule glucocorticoid receptor antagonist | Approval | US | Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer with nab-paclitaxel source |
| Q1 2026 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Approval | US | Relapsed/refractory myeloma after ≥1 prior line, with daratumumab (MajesTEC-3) source |
| Q1 2026 | Zongertinib Small-molecule kinase inhibitor (HER2) | Approval | US | First-line HER2-mutant non-squamous NSCLC source |
| 30 Jan 2026 | Camrelizumab + rivoceranib PD-1 antibody + oral VEGFR2 inhibitor | Filing / deal | US | Resubmission accepted; PDUFA 23 July 2026 source |
| 29 Jan 2026 | Galleri Multi-cancer early detection blood test | Filing / deal | US | Final PMA module submitted source |
| 16 Jan 2026 | Epcoritamab Bispecific T-cell engager (CD20×CD3) | Filing / deal | US | EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met source |
| Jan 2026 | Ivonescimab Bispecific antibody (PD-1×VEGF) | Filing / deal | US | BLA submitted by Summit for EGFR-mutant NSCLC after TKI (HARMONi) source |
| Dec 2025 | Daraxonrasib Small-molecule pan-RAS(ON) inhibitor | Filing / deal | US | RASolute 302 phase 3 fully enrolled; topline 2026 source |
| Dec 2025 | Filing / deal | China | First-line urothelial cancer with toripalimab, positive phase 3 source | |
| Dec 2025 | Tarlatamab Bispecific T-cell engager (DLL3×CD3) | Approval | US | Full approval based on DeLLphi-304 source |
| Dec 2025 | Zanidatamab Biparatopic bispecific antibody (HER2) | Filing / deal | US | First-line HER2+ gastro-oesophageal adenocarcinoma (HERIZON-GEA-01) submission source |
| 3 Dec 2025 | Pirtobrutinib Small-molecule non-covalent (reversible) BTK inhibitor | Approval | US | Traditional approval; label broadened to any prior covalent BTKi source |
| Nov 2025 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | Perioperative gastric/GEJ cancer with FLOT (MATTERHORN) source |
| Q4 2025 | Filing / deal | US | Muscle-invasive bladder cancer (EV-303/304) submissions following positive results source | |
| 13 Nov 2025 | Ziftomenib Small-molecule menin inhibitor | Approval | US | KOMET-001; priority review source |
| Oct 2025 | Approval | US | Approval in combination regimens for relapsed/refractory myeloma after ≥1 line (DREAMM-7/8) source | |
| Oct 2025 | Cemiplimab Monoclonal antibody (anti-PD-1) | Approval | US | Adjuvant high-risk CSCC after surgery and radiation (C-POST) source |
| Oct 2025 | Revumenib Small-molecule menin inhibitor | Approval | US | Relapsed/refractory NPM1-mutant AML source |
| 2 Oct 2025 | Lurbinectedin Cytotoxic (transcription inhibitor) | Approval | US | Full approval with atezolizumab as first-line maintenance (IMforte) source |
| 25 Sept 2025 | Imlunestrant Oral SERD | Approval | US | Approved as Inluriyo source |
| Sept 2025 | Amivantamab Bispecific antibody (EGFR×MET) | Approval | US | Subcutaneous formulation (PALOMA-3) source |
| Sept 2025 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | Subcutaneous pembrolizumab (Keytruda Qlex) source |
| Sept 2025 | Satricabtagene autoleucel CAR-T (Claudin 18.2) | Approval | China | First CAR-T approved for a solid tumour (CLDN18.2+ gastric/GEJ adenocarcinoma) source |
| 9 Sept 2025 | Gemcitabine intravesical system (TAR-200) Intravesical drug-eluting device | Approval | US | FDA approval of Inlexzo source |
| Aug 2025 | Afamitresgene autoleucel TCR-T (MAGE-A4) | Filing / deal | US | US rights sold by Adaptimmune to US WorldMeds source |
| 14 Aug 2025 | ArteraAI Prostate AI digital pathology prognostic/predictive test | Approval | US | De novo authorisation: first AI pathology test cleared for prognostic and predictive use in localised prostate cancer source |
| 8 Aug 2025 | Zongertinib Small-molecule kinase inhibitor (HER2) | Approval | US | Accelerated approval, previously treated HER2-mutant non-squamous NSCLC (Beamion LUNG-1) source |
| 4 Aug 2025 | Letetresgene autoleucel TCR-T (NY-ESO-1) | Filing / deal | US | Asset transferred to US WorldMeds; BLA committed by end-2026 |
| 30 Jul 2025 | Odronextamab Bispecific T-cell engager (CD20×CD3) | Approval | US | Accelerated approval in follicular lymphoma |
| 23 Jul 2025 | Complete response letter | US | Complete response letter on combination filing; resubmitted source | |
| 22 Jul 2025 | Vusolimogene oderparepvec Oncolytic virus (HSV-1) | Complete response letter | US | Complete response letter citing trial design and heterogeneity source |
| 2 Jul 2025 | Glofitamab Bispecific T-cell engager (CD20×CD3, 2:1) | Complete response letter | US | Complete response letter for STARGLO combination (regional heterogeneity); approved in EU source |
| 2 Jul 2025 | Linvoseltamab Bispecific T-cell engager (BCMA×CD3) | Approval | US | Accelerated approval (LINKER-MM1) source |
| 2025 | Eflornithine (DFMO) Small-molecule ornithine decarboxylase inhibitor | Filing / deal | EU | MAA submitted to EMA, UK, Australia, Switzerland source |
| 2025 | Nirogacestat Small-molecule gamma-secretase inhibitor | Approval | EU | European Commission approval source |
| 2025 | Designation | US | Breakthrough Therapy designation, advanced endometrial cancer after PD-(L)1 and platinum source | |
| 2025 | Serplulimab Monoclonal antibody (anti-PD-1) | Approval | UK | MHRA approval source |
| 27 Jun 2025 | Tisagenlecleucel CAR-T (CD19) | Label change | US | REMS requirements removed for approved CAR-T products |
| 23 Jun 2025 | Approval | US | EGFR-mutant NSCLC after TKI and platinum chemotherapy (accelerated) source | |
| Jun 2025 | Adagrasib Small-molecule inhibitor (KRAS G12C) | Approval | US | Full approval in NSCLC (KRYSTAL-12) source |
| Jun 2025 | Ciltacabtagene autoleucel CAR-T (BCMA) | Label change | US | REMS requirements removed for CAR-T class source |
| Jun 2025 | Dostarlimab Monoclonal antibody (anti-PD-1) | Designation | US | Breakthrough Therapy designation, dMMR locally advanced rectal cancer (organ preservation) source |
| Jun 2025 | Inavolisib Small-molecule PI3Kα inhibitor and degrader | Label change | US | OS benefit added to label source |
| Jun 2025 | Lifileucel TIL cell therapy | Approval | EU | Conditional marketing authorisation source |
| Jun 2025 | Relacorilant Small-molecule glucocorticoid receptor antagonist | Filing / deal | US | NDA submitted (ROSELLA) source |
| Jun 2025 | Shield Blood-based colorectal cancer screening test | Designation | US | Breakthrough Device designation for Shield multi-cancer (MCD) source |
| Jun 2025 | Tarlatamab Bispecific T-cell engager (DLL3×CD3) | Filing / deal | US | Phase 3 DeLLphi-304 OS benefit presented; conversion to full approval pursued source |
| Jun 2025 | Vepdegestrant PROTAC oestrogen receptor degrader | Filing / deal | US | NDA submitted (VERITAC-2) source |
| Jun 2025 | Vorasidenib Small-molecule IDH1/2 inhibitor | Approval | EU | EMA approval source |
| 1 Jun 2025 | Camizestrant Oral SERD | Filing / deal | US | NDA based on SERENA-6 |
| May 2025 | Belzutifan Small-molecule HIF-2α inhibitor | Approval | US | Pheochromocytoma/paraganglioma source |
| May 2025 | Gedatolisib Small-molecule pan-PI3K/mTOR inhibitor | Designation | US | Breakthrough Therapy designation, PIK3CA-wild-type HR+/HER2- breast cancer after CDK4/6 source |
| May 2025 | Withdrawal | US | BLA withdrawn after HERTHENA-Lung02 met PFS but not OS source | |
| May 2025 | Approval | China | HER2-mutant NSCLC source | |
| 14 May 2025 | Approval | US | Accelerated approval, previously treated c-MET-high non-squamous NSCLC (LUMINOSITY) source | |
| 8 May 2025 | Avutometinib + defactinib Small-molecule RAF/MEK clamp + FAK inhibitor | Approval | US | Accelerated approval on RAMP 201; RAMP 301 confirmatory source |
| Apr 2025 | Ipilimumab Monoclonal antibody (anti-CTLA-4) | Approval | US | With nivolumab first-line MSI-H/dMMR colorectal cancer (CheckMate 8HW) source |
| Apr 2025 | Ivonescimab Bispecific antibody (PD-1×VEGF) | Approval | China | First-line PD-L1+ NSCLC (HARMONi-2) source |
| 28 Mar 2025 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | Perioperative muscle-invasive bladder cancer (NIAGARA) source |
| 28 Mar 2025 | Lutetium-177 vipivotide tetraxetan Radioligand therapy (beta) | Approval | US | PSMA+ mCRPC after ARPI, before chemotherapy (PSMAfore) source |
| 26 Mar 2025 | Cabozantinib Small-molecule multi-kinase inhibitor (MET, VEGFR2, AXL, RET) | Approval | US | NET indication on CABINET source |
| Mar 2025 | 177Lu-edotreotide Radioligand therapy (beta) | Designation | US | COMPETE topline at ENETS 2025 source |
| Mar 2025 | AK146D1 Bispecific ADC | Filing / deal | China | IND cleared; first-in-human phase 1 started source |
| Mar 2025 | Camrelizumab Monoclonal antibody (anti-PD-1) | Complete response letter | US | Second complete response letter |
| Mar 2025 | Camrelizumab + rivoceranib PD-1 antibody + oral VEGFR2 inhibitor | Complete response letter | US | Second CRL |
| Mar 2025 | Approval | JP | First approval worldwide for HR+/HER2- breast cancer (December 2024, Japan MHLW) source | |
| Mar 2025 | Approval | China | EGFR-mutant NSCLC after TKI failure source | |
| 4 Mar 2025 | Tislelizumab Monoclonal antibody (anti-PD-1) | Approval | US | First-line ESCC PD-L1 ≥1% (RATIONALE-306) |
| Feb 2025 | Serplulimab Monoclonal antibody (anti-PD-1) | Approval | EU | European Commission approval for ES-SCLC source |
| Feb 2025 | Filing / deal | China | Phase 3 vs T-DM1 in residual disease registered (NCT06830889) source | |
| 14 Feb 2025 | Vimseltinib Small-molecule kinase inhibitor (CSF1R) | Approval | US | MOTION source |
| 27 Jan 2025 | Approval | US | HER2-low and HER2-ultralow HR+ breast cancer after endocrine therapy (DESTINY-Breast06) source | |
| 17 Jan 2025 | Approval | US | HR+/HER2- metastatic breast cancer after endocrine therapy and chemotherapy (TROPION-Breast01) source | |
| 16 Jan 2025 | Sotorasib Small-molecule inhibitor (KRAS G12C) | Approval | US | KRAS G12C colorectal cancer with panitumumab (CodeBreaK 300) source |
| Jan 2025 | Panitumumab Monoclonal antibody (anti-EGFR) | Approval | US | With sotorasib for KRAS G12C mCRC (CodeBreaK 300) |
| 27 Dec 2024 | Nivolumab Monoclonal antibody (anti-PD-1) | Approval | US | Subcutaneous nivolumab (Opdivo Qvantig) source |
| 20 Dec 2024 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | First-line BRAF V600E mCRC with cetuximab and mFOLFOX6 (BREAKWATER, accelerated) source |
| Dec 2024 | Tislelizumab Monoclonal antibody (anti-PD-1) | Approval | US | First-line gastric/GEJ (RATIONALE-305) |
| 13 Dec 2024 | Cosibelimab Anti-PD-L1 monoclonal antibody (IgG1, ADCC-competent) | Approval | US | Approved for cSCC |
| 4 Dec 2024 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | Limited-stage SCLC after chemoradiation (ADRIATIC) source |
| 4 Dec 2024 | Zenocutuzumab Bispecific antibody (HER2×HER3) | Approval | US | Accelerated approval, NRG1-fusion NSCLC and pancreatic adenocarcinoma (eNRGy): first therapy for NRG1 fusions source |
| 3 Dec 2024 | Designation | US | Breakthrough Therapy designation, EGFR-mutant NSCLC after TKI source | |
| 20 Nov 2024 | Zanidatamab Biparatopic bispecific antibody (HER2) | Approval | US | Accelerated approval, previously treated HER2+ (IHC3+) biliary tract cancer (HERIZON-BTC-01) source |
| Nov 2024 | Approval | EU | EMA approval source | |
| 15 Nov 2024 | Revumenib Small-molecule menin inhibitor | Approval | US | Relapsed/refractory KMT2A-rearranged acute leukaemia, age ≥1: first menin inhibitor source |
| Nov 2024 | Withdrawal | US | Urothelial cancer indication voluntarily withdrawn after TROPiCS-04 source | |
| Nov 2024 | Approval | China | NMPA approval, pretreated advanced TNBC (OptiTROP-Breast01); first TROP2 ADC approved in China source | |
| 8 Nov 2024 | Obecabtagene autoleucel CAR-T (CD19, fast off-rate) | Approval | US | FELIX; approved without REMS source |
| 18 Oct 2024 | Zolbetuximab Monoclonal antibody (anti-Claudin 18.2) | Approval | US | SPOTLIGHT/GLOW; companion diagnostic VENTANA CLDN18 (43-14A) |
| 15 Oct 2024 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | Optune Lua, metastatic NSCLC after platinum (LUNAR) source |
| Oct 2024 | Filing / deal | US | Merck co-development of R-DXd under the Daiichi Sankyo alliance source | |
| 10 Oct 2024 | Inavolisib Small-molecule PI3Kα inhibitor and degrader | Approval | US | PIK3CA-mutant HR+/HER2- endocrine-resistant advanced breast cancer with palbociclib and fulvestrant (INAVO120) source |
| 25 Sept 2024 | Osimertinib Small-molecule kinase inhibitor (EGFR) | Approval | US | Unresectable stage III after chemoradiation (LAURA) source |
| 20 Sept 2024 | Isatuximab Monoclonal antibody (anti-CD38) | Approval | US | IMROZ frontline |
| 19 Sept 2024 | Amivantamab Bispecific antibody (EGFR×MET) | Approval | US | After osimertinib, with chemotherapy (MARIPOSA-2) source |
| 17 Sept 2024 | Ribociclib Small-molecule CDK4/6 inhibitor | Approval | US | Adjuvant stage II-III HR+/HER2- early breast cancer at high risk (NATALEE) source |
| Sept 2024 | Cadonilimab Bispecific antibody (PD-1×CTLA-4) | Approval | China | First-line cervical cancer (COMPASSION-16) source |
| 12 Sept 2024 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Subcutaneous atezolizumab (Tecentriq Hybreza) source |
| 19 Aug 2024 | Amivantamab Bispecific antibody (EGFR×MET) | Approval | US | First-line EGFR-mutant NSCLC with lazertinib (MARIPOSA) source |
| Aug 2024 | Designation | US | Breakthrough Therapy designation, extensive-stage SCLC after platinum source | |
| Aug 2024 | Odronextamab Bispecific T-cell engager (CD20×CD3) | Approval | EU | Conditional approval DLBCL and FL |
| Aug 2024 | Shield Blood-based colorectal cancer screening test | Approval | US | Medicare coverage under the blood-based CRC screening NCD source |
| 6 Aug 2024 | Vorasidenib Small-molecule IDH1/2 inhibitor | Approval | US | Grade 2 IDH-mutant astrocytoma or oligodendroglioma after surgery, age ≥12 (INDIGO): first targeted therapy for low-grade glioma source |
| 1 Aug 2024 | Afamitresgene autoleucel TCR-T (MAGE-A4) | Approval | US | Accelerated approval, MAGE-A4+ HLA-A*02+ advanced synovial sarcoma (SPEARHEAD-1): first TCR-T for a solid tumour source |
| 1 Aug 2024 | Dostarlimab Monoclonal antibody (anti-PD-1) | Approval | US | All-comer primary advanced/recurrent endometrial cancer with chemotherapy source |
| 30 Jul 2024 | Daratumumab Monoclonal antibody (anti-CD38) | Approval | US | Dara-VRd induction/consolidation (PERSEUS) |
| 29 Jul 2024 | Shield Blood-based colorectal cancer screening test | Approval | US | PMA approval: first blood test for primary colorectal cancer screening (ECLIPSE) source |
| 2024 | Brenetafusp ImmTAC (PRAME TCR × CD3 bispecific) | Designation | US | Phase 3 PRISM-MEL-301 initiated after FDA alignment on design |
| 2024 | Petosemtamab Bispecific antibody (EGFR × LGR5) | Designation | US | Breakthrough Therapy designation for HNSCC |
| 26 Jun 2024 | Complete response letter | US | Complete response letter citing third-party manufacturing inspection source | |
| 21 Jun 2024 | Adagrasib Small-molecule inhibitor (KRAS G12C) | Approval | US | KRAS G12C colorectal cancer with cetuximab (accelerated) source |
| Jun 2024 | Actinium-225 PSMA agents Targeted alpha therapy | Filing / deal | US | AstraZeneca completes Fusion Pharmaceuticals acquisition; FPI-2265 phase 3 planned source |
| Jun 2024 | Daraxonrasib Small-molecule pan-RAS(ON) inhibitor | Designation | US | Breakthrough Therapy designation, previously treated metastatic PDAC source |
| Jun 2024 | Letetresgene autoleucel TCR-T (NY-ESO-1) | Designation | US | Breakthrough Therapy for MRCLS |
| Jun 2024 | Lutetium-177 dotatate Radioligand therapy (beta) | Label change | US | First-line label based on NETTER-2 source |
| Jun 2024 | Zidesamtinib Small-molecule kinase inhibitor (ROS1) | Designation | US | Breakthrough Therapy designation, ROS1+ NSCLC after prior ROS1 TKI source |
| 14 Jun 2024 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Approval | US | Consolidation in CD19+ Ph-negative B-ALL regardless of MRD (E1910) source |
| 29 May 2024 | Selpercatinib Small-molecule kinase inhibitor (RET) | Approval | US | Paediatric ≥2 years source |
| 24 May 2024 | Ivonescimab Bispecific antibody (PD-1×VEGF) | Approval | China | EGFR-mutant NSCLC after TKI, with chemotherapy (HARMONi-A) source |
| 23 May 2024 | Shield Blood-based colorectal cancer screening test | Advisory committee | US | FDA advisory committee votes favourably source |
| 16 May 2024 | Tarlatamab Bispecific T-cell engager (DLL3×CD3) | Approval | US | Accelerated approval, ES-SCLC after platinum (DeLLphi-301) source |
| May 2024 | Camrelizumab Monoclonal antibody (anti-PD-1) | Complete response letter | US | Complete response letter for camrelizumab + rivoceranib in HCC (manufacturing/inspection) |
| May 2024 | Camrelizumab + rivoceranib PD-1 antibody + oral VEGFR2 inhibitor | Complete response letter | US | First CRL: manufacturing inspection findings |
| 29 Apr 2024 | Approval | US | Full approval with OS benefit (innovaTV 301) source | |
| 23 Apr 2024 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | US | Paediatric patients ≥12 years source |
| 18 Apr 2024 | Tisagenlecleucel CAR-T (CD19) | Label change | US | Class boxed warning for T-cell malignancies |
| 5 Apr 2024 | Ciltacabtagene autoleucel CAR-T (BCMA) | Approval | US | Relapsed myeloma after ≥1 prior line, lenalidomide-refractory (CARTITUDE-4) source |
| 5 Apr 2024 | Approval | US | HER2 IHC3+ solid tumours, tumour-agnostic (accelerated) source | |
| 25 Mar 2024 | Odronextamab Bispecific T-cell engager (CD20×CD3) | Complete response letter | US | CRLs for DLBCL and FL, confirmatory trial enrolment status |
| 22 Mar 2024 | Approval | US | Full approval with OS benefit (MIRASOL) source | |
| 19 Mar 2024 | Ponatinib Small-molecule kinase inhibitor (pan-BCR::ABL1 incl. T315I) | Approval | US | Frontline Ph+ ALL (PhALLCON), accelerated |
| Mar 2024 | Tislelizumab Monoclonal antibody (anti-PD-1) | Approval | US | Second-line ESCC (RATIONALE-302) |
| Mar 2024 | Zolbetuximab Monoclonal antibody (anti-Claudin 18.2) | Approval | Japan | World-first approval |
| Mar 2024 | Zongertinib Small-molecule kinase inhibitor (HER2) | Designation | US | Breakthrough Therapy designation source |
| 14 Mar 2024 | Lisocabtagene maraleucel CAR-T (CD19, defined CD4:CD8) | Approval | US | First CAR-T in CLL (TRANSCEND CLL 004), accelerated |
| 6 Mar 2024 | Label change | US | Paediatric expansion | |
| 1 Mar 2024 | Amivantamab Bispecific antibody (EGFR×MET) | Approval | US | First-line exon 20 insertion with chemotherapy (PAPILLON) source |
| 26 Feb 2024 | Actinium-225 DOTATATE Targeted alpha therapy | Filing / deal | US | BMS completes RayzeBio acquisition ($4.1B) source |
| 20 Feb 2024 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Label change | US | Biweekly dosing added for responders source |
| 16 Feb 2024 | Lifileucel TIL cell therapy | Approval | US | Accelerated approval, unresectable/metastatic melanoma after anti-PD-1 (C-144-01): first TIL therapy source |
| 16 Feb 2024 | Osimertinib Small-molecule kinase inhibitor (EGFR) | Approval | US | First-line with chemotherapy (FLAURA2) source |
| Feb 2024 | Vepdegestrant PROTAC oestrogen receptor degrader | Designation | US | Fast Track designation source |
| 19 Jan 2024 | Axicabtagene ciloleucel CAR-T (CD19) | Label change | US | Class boxed warning for T-cell malignancies source |
| 19 Jan 2024 | Ciltacabtagene autoleucel CAR-T (BCMA) | Label change | US | Class boxed warning for T-cell malignancies source |
| Dec 2023 | Cosibelimab Anti-PD-L1 monoclonal antibody (IgG1, ADCC-competent) | Complete response letter | US | Complete response letter citing third-party manufacturing inspection findings |
| 15 Dec 2023 | Approval | US | Full approval with pembrolizumab, all first-line advanced urothelial cancer (EV-302) source | |
| Dec 2023 | Filing / deal | US | BLA submitted (HERTHENA-Lung01) source | |
| Dec 2023 | Sotorasib Small-molecule inhibitor (KRAS G12C) | Complete response letter | US | FDA declines full approval based on CodeBreaK 200; postmarketing dose study required source |
| 14 Dec 2023 | Belzutifan Small-molecule HIF-2α inhibitor | Approval | US | Advanced RCC after PD-1/PD-L1 and VEGF-TKI (LITESPARK-005) source |
| 13 Dec 2023 | Eflornithine (DFMO) Small-molecule ornithine decarboxylase inhibitor | Approval | US | First oral maintenance therapy; externally controlled evidence source |
| 11 Dec 2023 | Izalontamab brengitecan Bispecific ADC | Filing / deal | US | BMS licenses global rights ex-China from SystImmune (up to $8.4B) source |
| 1 Dec 2023 | Pirtobrutinib Small-molecule non-covalent (reversible) BTK inhibitor | Approval | US | CLL/SLL accelerated approval |
| 27 Nov 2023 | Nirogacestat Small-molecule gamma-secretase inhibitor | Approval | US | First systemic therapy for desmoid tumours (DeFi) source |
| 16 Nov 2023 | Capivasertib Small-molecule AKT inhibitor | Approval | US | HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alteration, with fulvestrant (CAPItello-291): first AKT inhibitor source |
| Nov 2023 | Vusolimogene oderparepvec Oncolytic virus (HSV-1) | Designation | US | Breakthrough Therapy designation, anti-PD-1-failed melanoma source |
| 8 Nov 2023 | Fruquintinib Small-molecule kinase inhibitor (VEGFR1-3) | Approval | US | FRESCO-2 |
| 27 Oct 2023 | Toripalimab Monoclonal antibody (anti-PD-1) | Approval | US | First FDA approval for nasopharyngeal carcinoma |
| 16 Oct 2023 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | Perioperative NSCLC (KEYNOTE-671) source |
| 11 Oct 2023 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | BRAF V600E NSCLC with binimetinib source |
| Sept 2023 | Elacestrant Oral SERD | Approval | EU | EMA approval source |
| Aug 2023 | Bevacizumab Monoclonal antibody (anti-VEGF) | Label change | US | With trifluridine/tipiracil in refractory mCRC |
| Aug 2023 | Trifluridine/tipiracil Cytotoxic chemotherapy (oral nucleoside) | Approval | US | SUNLIGHT combination |
| 11 Aug 2023 | Niraparib Small-molecule PARP inhibitor | Approval | US | Niraparib + abiraterone (Akeega) for BRCA-mutated mCRPC (MAGNITUDE) source |
| 31 Jul 2023 | Dostarlimab Monoclonal antibody (anti-PD-1) | Approval | US | dMMR primary advanced/recurrent endometrial cancer with chemotherapy (RUBY) source |
| 20 Jul 2023 | Quizartinib Small-molecule kinase inhibitor (FLT3-ITD, type II) | Approval | US | Frontline FLT3-ITD AML (QuANTUM-First) |
| Jul 2023 | Glofitamab Bispecific T-cell engager (CD20×CD3, 2:1) | Approval | EU | Conditional marketing authorisation source |
| 20 Jun 2023 | Talazoparib Small-molecule PARP inhibitor | Approval | US | HRR-mutant mCRPC with enzalutamide (TALAPRO-2) source |
| 15 Jun 2023 | Glofitamab Bispecific T-cell engager (CD20×CD3, 2:1) | Approval | US | Accelerated approval, relapsed/refractory DLBCL after ≥2 lines source |
| 31 May 2023 | Olaparib Small-molecule PARP inhibitor | Approval | US | With abiraterone in BRCA-mutated mCRPC (PROpel) source |
| 19 May 2023 | Epcoritamab Bispecific T-cell engager (CD20×CD3) | Approval | US | Accelerated approval in DLBCL (EPCORE NHL-1) |
| May 2023 | Lifileucel TIL cell therapy | Filing / deal | US | BLA submitted source |
| 19 Apr 2023 | Approval | US | Frontline Pola-R-CHP (POLARIX) | |
| Apr 2023 | Intismeran autogene Personalised mRNA neoantigen vaccine | Designation | EU | PRIME designation source |
| 6 Apr 2023 | Ibrutinib Small-molecule covalent BTK inhibitor (first generation) | Withdrawal | US | MCL and MZL indications voluntarily withdrawn after confirmatory trials missed |
| 3 Apr 2023 | Approval | US | Accelerated approval with pembrolizumab, cisplatin-ineligible first line source | |
| Mar 2023 | Vorasidenib Small-molecule IDH1/2 inhibitor | Designation | US | Breakthrough Therapy designation source |
| 3 Mar 2023 | Abemaciclib Small-molecule CDK4/6 inhibitor | Label change | US | Adjuvant indication broadened to remove Ki-67 requirement source |
| 22 Feb 2023 | Intismeran autogene Personalised mRNA neoantigen vaccine | Designation | US | Breakthrough Therapy designation, adjuvant melanoma source |
| Feb 2023 | Filing / deal | US | AstraZeneca licenses global rights from KYM Biosciences source | |
| 3 Feb 2023 | Approval | US | HR+/HER2- metastatic breast cancer after endocrine therapy and ≥2 chemotherapies (TROPiCS-02) source | |
| 27 Jan 2023 | Elacestrant Oral SERD | Approval | US | ESR1-mutated ER+/HER2- advanced breast cancer after ≥1 endocrine therapy (EMERALD): first oral SERD source |
| 19 Jan 2023 | Tucatinib Small-molecule kinase inhibitor (HER2) | Approval | US | HER2+ RAS wild-type metastatic colorectal cancer with trastuzumab (MOUNTAINEER, accelerated) source |
| 19 Jan 2023 | Zanubrutinib Small-molecule covalent BTK inhibitor (second generation) | Approval | US | CLL/SLL source |
| Jan 2023 | FAP-2286 (177Lu / 68Ga) Theranostic pair (peptide radioligand) | Filing / deal | US | Novartis acquires rights after Clovis bankruptcy source |
| Jan 2023 | Zanidatamab Biparatopic bispecific antibody (HER2) | Designation | US | Breakthrough Therapy designation, HER2+ biliary tract cancer source |
| Dec 2022 | Approval | EU | Conditional marketing authorisation source | |
| Dec 2022 | Lutetium-177 vipivotide tetraxetan Radioligand therapy (beta) | Approval | EU | EMA approval source |
| Dec 2022 | Nonavalent HPV vaccine Prophylactic vaccine (virus-like particles) | Label change | WHO | One-dose schedule endorsed (SAGE) |
| Dec 2022 | Revumenib Small-molecule menin inhibitor | Designation | US | Breakthrough Therapy designation source |
| 12 Dec 2022 | Adagrasib Small-molecule inhibitor (KRAS G12C) | Approval | US | Accelerated approval, KRAS G12C NSCLC after ≥1 therapy source |
| 11 Dec 2022 | Rucaparib Small-molecule PARP inhibitor | Withdrawal | US | Clovis Oncology bankruptcy; asset sold to pharma& |
| 1 Dec 2022 | Olutasidenib Small-molecule IDH1 inhibitor | Approval | US | Study 2102-HEM-101 pivotal cohort |
| 22 Nov 2022 | Withdrawal | US | Withdrawn after DREAMM-3 failed to confirm benefit source | |
| Nov 2022 | Niraparib Small-molecule PARP inhibitor | Label change | US | Second-line maintenance restricted to gBRCA after OS data source |
| Nov 2022 | Tarlatamab Bispecific T-cell engager (DLL3×CD3) | Designation | US | Breakthrough Therapy designation, ES-SCLC after platinum source |
| 14 Nov 2022 | Approval | US | Accelerated approval, FRα-high platinum-resistant ovarian cancer (SORAYA) source | |
| 10 Nov 2022 | Approval | US | Paediatric high-risk Hodgkin lymphoma source | |
| 25 Oct 2022 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Approval | US | Accelerated approval, relapsed/refractory myeloma after ≥4 lines (MajesTEC-1) source |
| 21 Oct 2022 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | HCC with tremelimumab (HIMALAYA) source |
| 21 Sept 2022 | Selpercatinib Small-molecule kinase inhibitor (RET) | Approval | US | RET-fusion solid tumours (tumour-agnostic, accelerated); full approval in NSCLC source |
| Sept 2022 | Relatlimab + nivolumab Fixed-dose bispecific combination (anti-LAG-3 + anti-PD-1) | Approval | EU | EMA approval, PD-L1 <1% melanoma source |
| 2 Sept 2022 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | Biliary tract cancer with chemotherapy (TOPAZ-1) source |
| 24 Aug 2022 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Approval | EU | Conditional approval: first BCMA bispecific worldwide source |
| 11 Aug 2022 | Approval | US | HER2-mutant NSCLC (accelerated) source | |
| 5 Aug 2022 | Approval | US | HER2-low metastatic breast cancer (DESTINY-Breast04); first HER2-low indication source | |
| 3 Aug 2022 | Acalabrutinib Small-molecule covalent BTK inhibitor (second generation) | Label change | US | Tablet formulation co-administrable with acid-reducing agents |
| 29 Jun 2022 | Cadonilimab Bispecific antibody (PD-1×CTLA-4) | Approval | China | First PD-1×CTLA-4 bispecific approved anywhere |
| Jun 2022 | Rucaparib Small-molecule PARP inhibitor | Label change | US | Later-line treatment indication withdrawn after ARIEL4 OS imbalance |
| 25 May 2022 | Ivosidenib Small-molecule IDH1 inhibitor | Approval | US | Combination with azacitidine (AGILE) |
| May 2022 | Ripretinib Small-molecule kinase inhibitor (KIT/PDGFRA switch-control) | Label change | US | Label updated with INTRIGUE data |
| May 2022 | Filing / deal | China | Merck licenses ex-Greater-China rights (deal expanded December 2022) source | |
| 4 May 2022 | Approval | US | Second-line HER2+ metastatic breast cancer (DESTINY-Breast03) source | |
| Apr 2022 | Paclitaxel / nab-paclitaxel Cytotoxic chemotherapy (taxane) | Approval | US | First nab-paclitaxel generics source |
| Apr 2022 | Tebentafusp ImmTAC (TCR×CD3 bispecific) | Approval | EU | EMA approval source |
| 1 Apr 2022 | Axicabtagene ciloleucel CAR-T (CD19) | Approval | US | Second-line LBCL refractory or relapsed within 12 months (ZUMA-7) source |
| 23 Mar 2022 | Lutetium-177 vipivotide tetraxetan Radioligand therapy (beta) | Approval | US | PSMA+ mCRPC after ARPI and taxane (VISION) source |
| 18 Mar 2022 | Relatlimab + nivolumab Fixed-dose bispecific combination (anti-LAG-3 + anti-PD-1) | Approval | US | Unresectable or metastatic melanoma, age ≥12 (RELATIVITY-047): first LAG-3 therapy source |
| Mar 2022 | Lenalidomide Immunomodulatory drug (cereblon E3 ligase modulator) | Label change | US | First generics launch (volume-limited) |
| 11 Mar 2022 | Olaparib Small-molecule PARP inhibitor | Approval | US | Adjuvant gBRCA high-risk HER2-negative early breast cancer (OlympiA) source |
| 4 Mar 2022 | Nivolumab Monoclonal antibody (anti-PD-1) | Approval | US | Neoadjuvant NSCLC with chemotherapy (CheckMate 816) source |
| 28 Feb 2022 | Ciltacabtagene autoleucel CAR-T (BCMA) | Approval | US | Relapsed/refractory myeloma after ≥4 lines (CARTITUDE-1) source |
| 25 Jan 2022 | Tebentafusp ImmTAC (TCR×CD3 bispecific) | Approval | US | HLA-A*02:01+ unresectable or metastatic uveal melanoma: first TCR therapeutic approved source |
| Jan 2022 | Satricabtagene autoleucel CAR-T (Claudin 18.2) | Designation | US | RMAT designation, CLDN18.2+ gastric cancer source |
| Jan 2022 | Designation | US | Breakthrough Therapy designation, c-MET overexpressing NSCLC source | |
| 31 Dec 2021 | Approval | China | HER2-expressing urothelial cancer after platinum source | |
| 23 Dec 2021 | Designation | US | Breakthrough Therapy designation, EGFR-mutant NSCLC after TKI and platinum source | |
| 22 Nov 2021 | Approval | EU | EMA approval, pretreated metastatic TNBC source | |
| 15 Oct 2021 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Adjuvant NSCLC, PD-L1 ≥1% (IMpower010) source |
| Oct 2021 | Signatera Tumour-informed ctDNA MRD test | Approval | US | Medicare coverage for immunotherapy response monitoring, pan-cancer source |
| 12 Oct 2021 | Abemaciclib Small-molecule CDK4/6 inhibitor | Approval | US | Adjuvant high-risk node-positive HR+/HER2- early breast cancer, Ki-67 ≥20% (monarchE) source |
| 20 Sept 2021 | Approval | US | Accelerated approval, recurrent or metastatic cervical cancer after chemotherapy (innovaTV 204) source | |
| 27 Aug 2021 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Withdrawal | US | TNBC indication withdrawn after IMpassion131 source |
| 17 Aug 2021 | Dostarlimab Monoclonal antibody (anti-PD-1) | Approval | US | dMMR solid tumours (tumour-agnostic, accelerated) source |
| 13 Aug 2021 | Belzutifan Small-molecule HIF-2α inhibitor | Approval | US | VHL disease-associated RCC, CNS haemangioblastoma, pNET: first HIF-2α inhibitor source |
| 26 Jul 2021 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | High-risk early TNBC, neoadjuvant and adjuvant (KEYNOTE-522) source |
| 21 Jul 2021 | Lenvatinib Small-molecule multi-kinase inhibitor (VEGFR, FGFR, PDGFR, RET, KIT) | Approval | US | Full approval, pMMR endometrial cancer (KEYNOTE-775) |
| 9 Jul 2021 | Approval | US | Full approval and cisplatin-ineligible expansion (EV-301) source | |
| Jun 2021 | Adagrasib Small-molecule inhibitor (KRAS G12C) | Designation | US | Breakthrough Therapy designation source |
| Jun 2021 | Approval | China | Conditional approval, HER2+ gastric cancer after ≥2 lines source | |
| Jun 2021 | Galleri Multi-cancer early detection blood test | Filing / deal | US | Launched as a laboratory-developed test source |
| Jun 2021 | Lutetium-177 vipivotide tetraxetan Radioligand therapy (beta) | Designation | US | Breakthrough Therapy designation source |
| Jun 2021 | Teclistamab Bispecific T-cell engager (BCMA×CD3) | Designation | US | Breakthrough Therapy designation source |
| 28 May 2021 | Sotorasib Small-molecule inhibitor (KRAS G12C) | Approval | US | Accelerated approval, KRAS G12C NSCLC after ≥1 therapy: first KRAS inhibitor source |
| 26 May 2021 | Piflufolastat F-18 / Pylarify TruVu PET imaging agent | Approval | US | PSMA PET imaging in prostate cancer: first 18F PSMA agent source |
| 21 May 2021 | Amivantamab Bispecific antibody (EGFR×MET) | Approval | US | Accelerated approval, EGFR exon 20 insertion NSCLC after platinum source |
| 23 Apr 2021 | Approval | US | Accelerated approval, relapsed/refractory DLBCL after ≥2 lines (LOTIS-2) source | |
| 22 Apr 2021 | Dostarlimab Monoclonal antibody (anti-PD-1) | Approval | US | Accelerated approval, dMMR recurrent/advanced endometrial cancer after platinum source |
| 7 Apr 2021 | Approval | US | Full approval in metastatic TNBC (ASCENT); accelerated approval in urothelial cancer source | |
| 30 Mar 2021 | CPX-351 (liposomal daunorubicin-cytarabine) Liposomal cytotoxic formulation | Label change | US | Paediatric expansion |
| 5 Mar 2021 | Axicabtagene ciloleucel CAR-T (CD19) | Approval | US | Relapsed/refractory follicular lymphoma (ZUMA-5) source |
| 3 Mar 2021 | Lorlatinib Small-molecule kinase inhibitor (ALK/ROS1) | Approval | US | First-line ALK+ NSCLC (CROWN); full approval source |
| 22 Feb 2021 | Cemiplimab Monoclonal antibody (anti-PD-1) | Approval | US | First-line PD-L1 ≥50% NSCLC (EMPOWER-Lung 1) source |
| Feb 2021 | Tebentafusp ImmTAC (TCR×CD3 bispecific) | Designation | US | Breakthrough Therapy designation source |
| 9 Feb 2021 | Cemiplimab Monoclonal antibody (anti-PD-1) | Approval | US | Advanced basal cell carcinoma after hedgehog inhibitor source |
| 15 Jan 2021 | Approval | US | HER2+ gastric/GEJ adenocarcinoma (DESTINY-Gastric01) source | |
| 18 Dec 2020 | Osimertinib Small-molecule kinase inhibitor (EGFR) | Approval | US | Adjuvant EGFR-mutant NSCLC after resection (ADAURA) source |
| Dec 2020 | Oncotype DX Gene-expression prognostic/predictive assay | Label change | US | RxPONDER extends to 1-3 positive nodes (postmenopausal) source |
| Dec 2020 | Sotorasib Small-molecule inhibitor (KRAS G12C) | Designation | US | Breakthrough Therapy designation source |
| 25 Nov 2020 | Naxitamab Monoclonal antibody (anti-GD2, humanised) | Approval | US | Accelerated approval (Study 201, 12-230) |
| 13 Nov 2020 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | Metastatic TNBC, PD-L1 CPS ≥10, with chemotherapy (KEYNOTE-355) source |
| 16 Oct 2020 | Azacitidine Small-molecule hypomethylating agent (cytotoxic) | Approval | US | Venetoclax + azacitidine full approval in unfit AML (VIALE-A) |
| 16 Oct 2020 | Venetoclax Small-molecule BCL-2 inhibitor | Approval | US | Full approval in AML (VIALE-A) source |
| 2 Oct 2020 | Ipilimumab Monoclonal antibody (anti-CTLA-4) | Approval | US | With nivolumab in mesothelioma (CheckMate 743) source |
| 25 Sept 2020 | Cetuximab sarotalocan Photoimmunotherapy conjugate (anti-EGFR antibody–IR700 dye) | Approval | Japan | World-first approval of a photoimmunotherapy drug |
| Sept 2020 | Designation | US | Breakthrough Therapy designation, HER2+ urothelial cancer source | |
| 1 Sept 2020 | Azacitidine Small-molecule hypomethylating agent (cytotoxic) | Approval | US | Onureg maintenance in AML |
| 26 Aug 2020 | FoundationOne CDx / Liquid CDx Comprehensive genomic profiling test | Approval | US | FoundationOne Liquid CDx approved source |
| 5 Aug 2020 | Approval | US | Accelerated approval, relapsed/refractory myeloma after ≥4 lines (DREAMM-2) source | |
| 31 Jul 2020 | Tafasitamab Monoclonal antibody (anti-CD19, Fc-enhanced) | Approval | US | L-MIND accelerated approval |
| 7 Jul 2020 | Decitabine + cedazuridine (oral) Oral hypomethylating agent | Approval | US | MDS/CMML |
| 29 Jun 2020 | Pertuzumab Monoclonal antibody (anti-HER2, dimerisation domain) | Approval | US | Phesgo SC |
| 29 Jun 2020 | Trastuzumab Monoclonal antibody (anti-HER2) | Approval | US | Phesgo (pertuzumab, trastuzumab, hyaluronidase) subcutaneous source |
| 18 Jun 2020 | Tazemetostat Small-molecule EZH2 inhibitor | Approval | US | Accelerated approval, follicular lymphoma |
| 16 Jun 2020 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | TMB-high solid tumours (tumour-agnostic) source |
| Jun 2020 | FoundationOne CDx / Liquid CDx Comprehensive genomic profiling test | Label change | US | TMB ≥10 mut/Mb companion claim for pembrolizumab source |
| 15 Jun 2020 | Lurbinectedin Cytotoxic (transcription inhibitor) | Approval | US | Accelerated approval, second-line SCLC |
| 29 May 2020 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Unresectable HCC with bevacizumab (IMbrave150) source |
| 19 May 2020 | Olaparib Small-molecule PARP inhibitor | Approval | US | HRR-mutant mCRPC (PROfound) source |
| 15 May 2020 | Ipilimumab Monoclonal antibody (anti-CTLA-4) | Approval | US | With nivolumab in first-line NSCLC (CheckMate 227) and HCC source |
| 15 May 2020 | Ripretinib Small-molecule kinase inhibitor (KIT/PDGFRA switch-control) | Approval | US | INVICTUS |
| 8 May 2020 | Bevacizumab Monoclonal antibody (anti-VEGF) | Approval | US | With olaparib as HRD-positive maintenance (PAOLA-1) |
| 8 May 2020 | Selpercatinib Small-molecule kinase inhibitor (RET) | Approval | US | Accelerated approval, RET-fusion NSCLC and thyroid cancer, RET-mutant MTC (LIBRETTO-001) source |
| 1 May 2020 | Daratumumab Monoclonal antibody (anti-CD38) | Approval | US | Subcutaneous Darzalex Faspro |
| 29 Apr 2020 | Niraparib Small-molecule PARP inhibitor | Approval | US | First-line ovarian maintenance, all-comers (PRIMA) source |
| 22 Apr 2020 | Approval | US | Accelerated approval, metastatic TNBC after ≥2 prior therapies source | |
| 17 Apr 2020 | Tucatinib Small-molecule kinase inhibitor (HER2) | Approval | US | HER2+ metastatic breast cancer including brain metastases, with trastuzumab and capecitabine (HER2CLIMB) source |
| Apr 2020 | Cetuximab Monoclonal antibody (anti-EGFR) | Approval | US | With encorafenib for BRAF V600E mCRC (BEACON) |
| 8 Apr 2020 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | BRAF V600E metastatic CRC with cetuximab after prior therapy (BEACON) source |
| 27 Mar 2020 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | Extensive-stage SCLC with chemotherapy (CASPIAN) source |
| Mar 2020 | Signatera Tumour-informed ctDNA MRD test | Approval | US | Medicare coverage (MolDX) for stage II-III colorectal cancer source |
| 23 Jan 2020 | Tazemetostat Small-molecule EZH2 inhibitor | Approval | US | Accelerated approval, epithelioid sarcoma |
| 27 Dec 2019 | Olaparib Small-molecule PARP inhibitor | Approval | US | gBRCA metastatic pancreatic cancer maintenance (POLO) source |
| 20 Dec 2019 | Approval | US | Accelerated approval, HER2+ metastatic breast cancer after ≥2 anti-HER2 regimens (DESTINY-Breast01) source | |
| 18 Dec 2019 | Approval | US | Accelerated approval, advanced urothelial cancer after platinum and PD-1/PD-L1 (EV-201) source | |
| Dec 2019 | Ciltacabtagene autoleucel CAR-T (BCMA) | Designation | US | Breakthrough Therapy designation source |
| 1 Dec 2019 | Enasidenib Small-molecule IDH2 inhibitor | Withdrawal | EU | Marketing application withdrawn after EMA objections on efficacy source |
| 21 Nov 2019 | Acalabrutinib Small-molecule covalent BTK inhibitor (second generation) | Approval | US | CLL/SLL |
| 17 Sept 2019 | Lenvatinib Small-molecule multi-kinase inhibitor (VEGFR, FGFR, PDGFR, RET, KIT) | Approval | US | Accelerated approval with pembrolizumab in endometrial cancer (KEYNOTE-146) |
| 14 Jun 2019 | Quizartinib Small-molecule kinase inhibitor (FLT3-ITD, type II) | Complete response letter | US | Complete response letter for relapsed/refractory indication (QuANTUM-R) |
| 10 Jun 2019 | Approval | US | Accelerated approval with BR in R/R DLBCL | |
| 23 May 2019 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | Humanitarian device exemption, malignant pleural mesothelioma source |
| May 2019 | Signatera Tumour-informed ctDNA MRD test | Designation | US | FDA Breakthrough Device designation source |
| 15 May 2019 | Venetoclax Small-molecule BCL-2 inhibitor | Approval | US | First-line CLL with obinutuzumab (CLL14) source |
| 3 May 2019 | Approval | US | Adjuvant treatment of HER2+ early breast cancer with residual disease (KATHERINE) source | |
| 4 Apr 2019 | Palbociclib Small-molecule CDK4/6 inhibitor | Approval | US | Men with HR+/HER2- breast cancer source |
| 18 Mar 2019 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Extensive-stage SCLC with chemotherapy (IMpower133) source |
| 8 Mar 2019 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | PD-L1+ metastatic TNBC with nab-paclitaxel (accelerated; IMpassion130) source |
| 28 Feb 2019 | Trastuzumab Monoclonal antibody (anti-HER2) | Approval | US | Subcutaneous trastuzumab-hyaluronidase (Herceptin Hylecta) source |
| 19 Dec 2018 | Olaparib Small-molecule PARP inhibitor | Approval | US | First-line maintenance in BRCA-mutated ovarian cancer (SOLO-1) source |
| 28 Nov 2018 | Gilteritinib Small-molecule kinase inhibitor (FLT3, type I) | Approval | US | ADMIRAL interim; full OS data 2019 |
| 21 Nov 2018 | Venetoclax Small-molecule BCL-2 inhibitor | Approval | US | Newly diagnosed AML in unfit patients with azacitidine/decitabine/LDAC (accelerated) source |
| 16 Nov 2018 | Approval | US | First-line CD30+ peripheral T-cell lymphoma with CHP (ECHELON-2) source | |
| 2 Nov 2018 | Lorlatinib Small-molecule kinase inhibitor (ALK/ROS1) | Approval | US | ALK+ NSCLC after prior ALK TKIs (accelerated) source |
| 16 Oct 2018 | Talazoparib Small-molecule PARP inhibitor | Approval | US | gBRCA HER2-negative locally advanced/metastatic breast cancer (EMBRACA) source |
| 28 Sept 2018 | Cemiplimab Monoclonal antibody (anti-PD-1) | Approval | US | Advanced cutaneous squamous cell carcinoma: first systemic therapy approved for CSCC source |
| 20 Jul 2018 | Ivosidenib Small-molecule IDH1 inhibitor | Approval | US | First IDH1 inhibitor |
| 18 Jul 2018 | Ribociclib Small-molecule CDK4/6 inhibitor | Approval | US | Pre/perimenopausal women and with fulvestrant (MONALEESA-7/-3) source |
| 27 Jun 2018 | Binimetinib Small-molecule kinase inhibitor (MEK1/2) | Approval | US | Encorafenib + binimetinib approved for BRAF V600 melanoma |
| 27 Jun 2018 | Encorafenib Small-molecule kinase inhibitor (BRAF) | Approval | US | BRAF V600 melanoma with binimetinib (COLUMBUS) source |
| 13 Jun 2018 | Bevacizumab Monoclonal antibody (anti-VEGF) | Approval | US | First-line ovarian cancer (GOG-0218) |
| 8 Jun 2018 | Venetoclax Small-molecule BCL-2 inhibitor | Approval | US | CLL/SLL with rituximab (MURANO) source |
| 3 Jun 2018 | Oncotype DX Gene-expression prognostic/predictive assay | Label change | US | TAILORx results define recurrence score ≤25 as chemotherapy-sparing source |
| May 2018 | Galleri Multi-cancer early detection blood test | Designation | US | FDA Breakthrough Device designation source |
| 18 Apr 2018 | Osimertinib Small-molecule kinase inhibitor (EGFR) | Approval | US | First-line EGFR-mutant NSCLC (FLAURA) source |
| 16 Apr 2018 | Ipilimumab Monoclonal antibody (anti-CTLA-4) | Approval | US | With nivolumab in RCC source |
| 16 Apr 2018 | Nivolumab Monoclonal antibody (anti-PD-1) | Approval | US | With ipilimumab, intermediate/poor-risk RCC (CheckMate 214) source |
| 6 Apr 2018 | Rucaparib Small-molecule PARP inhibitor | Approval | US | Recurrent ovarian maintenance (ARIEL3) |
| 29 Mar 2018 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Approval | US | MRD-positive B-ALL: first approval based on MRD source |
| 20 Mar 2018 | Approval | US | First-line stage III/IV Hodgkin lymphoma with AVD (ECHELON-1) source | |
| Mar 2018 | Designation | US | Breakthrough Therapy designation source | |
| 26 Feb 2018 | Abemaciclib Small-molecule CDK4/6 inhibitor | Approval | US | With aromatase inhibitor first line (MONARCH 3) source |
| 16 Feb 2018 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | Unresectable stage III NSCLC after chemoradiation (PACIFIC) source |
| 26 Jan 2018 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | US | SSTR+ gastroenteropancreatic NETs (NETTER-1) source |
| 12 Jan 2018 | Olaparib Small-molecule PARP inhibitor | Approval | US | gBRCA HER2-negative metastatic breast cancer (OlympiAD) source |
| 20 Dec 2017 | Pertuzumab Monoclonal antibody (anti-HER2, dimerisation domain) | Approval | US | Adjuvant (APHINITY) |
| 1 Dec 2017 | Trastuzumab Monoclonal antibody (anti-HER2) | Approval | US | First trastuzumab biosimilar (Ogivri) source |
| 30 Nov 2017 | FoundationOne CDx / Liquid CDx Comprehensive genomic profiling test | Approval | US | FDA approval and parallel Medicare NCD: first FDA-approved broad CGP companion diagnostic source |
| 18 Oct 2017 | Axicabtagene ciloleucel CAR-T (CD19) | Approval | US | Relapsed/refractory large B-cell lymphoma after ≥2 lines (ZUMA-1): second CAR-T ever approved source |
| 28 Sept 2017 | Abemaciclib Small-molecule CDK4/6 inhibitor | Approval | US | With fulvestrant after endocrine therapy, and as monotherapy after chemotherapy (MONARCH 2/1) source |
| 26 Sept 2017 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | EU | EMA approval: first modern PRRT source |
| Sept 2017 | Bevacizumab Monoclonal antibody (anti-VEGF) | Approval | US | First biosimilar (bevacizumab-awwb) approved |
| 1 Sept 2017 | Approval | US | Re-approval at lower fractionated dose for newly diagnosed and relapsed CD33+ AML (ALFA-0701) source | |
| 30 Aug 2017 | Tisagenlecleucel CAR-T (CD19) | Approval | US | First CAR-T approval in history |
| 17 Aug 2017 | Approval | US | INO-VATE | |
| 17 Aug 2017 | Olaparib Small-molecule PARP inhibitor | Approval | US | Maintenance in platinum-sensitive recurrent ovarian cancer; tablet formulation source |
| Aug 2017 | Designation | US | Breakthrough Therapy designation, HER2+ breast cancer source | |
| 3 Aug 2017 | CPX-351 (liposomal daunorubicin-cytarabine) Liposomal cytotoxic formulation | Approval | US | Adults |
| 1 Aug 2017 | Enasidenib Small-molecule IDH2 inhibitor | Approval | US | Single-arm AG221-C-001 |
| 11 Jul 2017 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Approval | US | Full approval including Ph+ ALL source |
| 23 May 2017 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | MSI-H/dMMR solid tumours: first tumour-agnostic approval source |
| May 2017 | Dinutuximab (ch14.18) / dinutuximab beta Monoclonal antibody (anti-GD2, chimeric) | Approval | EU | Dinutuximab beta (Qarziba) |
| 1 May 2017 | Durvalumab Monoclonal antibody (anti-PD-L1) | Approval | US | Urothelial carcinoma (accelerated; later withdrawn 2021) source |
| 28 Apr 2017 | Midostaurin Small-molecule multikinase inhibitor (FLT3) | Approval | US | First FLT3 inhibitor approved |
| 31 Mar 2017 | Palbociclib Small-molecule CDK4/6 inhibitor | Approval | US | Full approval (PALOMA-2) source |
| 30 Mar 2017 | Osimertinib Small-molecule kinase inhibitor (EGFR) | Approval | US | Full approval (AURA3) source |
| 27 Mar 2017 | Niraparib Small-molecule PARP inhibitor | Approval | US | Maintenance in recurrent ovarian cancer regardless of BRCA (NOVA) source |
| 13 Mar 2017 | Ribociclib Small-molecule CDK4/6 inhibitor | Approval | US | With aromatase inhibitor, HR+/HER2- advanced breast cancer (MONALEESA-2) source |
| 19 Dec 2016 | Rucaparib Small-molecule PARP inhibitor | Approval | US | Accelerated approval, gBRCA/sBRCA ovarian, ≥2 prior lines |
| 18 Oct 2016 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | NSCLC after platinum source |
| 18 May 2016 | Atezolizumab Monoclonal antibody (anti-PD-L1) | Approval | US | Urothelial carcinoma after platinum (accelerated; later withdrawn) source |
| 11 Apr 2016 | Venetoclax Small-molecule BCL-2 inhibitor | Approval | US | CLL with 17p deletion after ≥1 therapy: first BCL-2 inhibitor source |
| 4 Mar 2016 | Ibrutinib Small-molecule covalent BTK inhibitor (first generation) | Approval | US | First-line CLL |
| 19 Feb 2016 | Palbociclib Small-molecule CDK4/6 inhibitor | Approval | US | With fulvestrant after endocrine therapy (PALOMA-3) source |
| 5 Feb 2016 | Designation | US | Breakthrough Therapy designation for pretreated metastatic TNBC source | |
| 1 Feb 2016 | Imatinib Small-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA) | Approval | US | First US generic imatinib launched source |
| Dec 2015 | Talimogene laherparepvec Oncolytic virus (HSV-1) | Approval | EU | EMA approval source |
| 16 Nov 2015 | Daratumumab Monoclonal antibody (anti-CD38) | Approval | US | First CD38 antibody |
| 13 Nov 2015 | Osimertinib Small-molecule kinase inhibitor (EGFR) | Approval | US | Accelerated approval, EGFR T790M NSCLC after TKI source |
| 10 Nov 2015 | Vemurafenib Small-molecule kinase inhibitor (BRAF V600) | Approval | US | Cobimetinib approved in combination (coBRIM) |
| 28 Oct 2015 | Ipilimumab Monoclonal antibody (anti-CTLA-4) | Approval | US | Adjuvant stage III melanoma (10 mg/kg; later superseded) source |
| 27 Oct 2015 | Talimogene laherparepvec Oncolytic virus (HSV-1) | Approval | US | Unresectable melanoma with injectable lesions (OPTiM): first oncolytic virus approved in the US source |
| 5 Oct 2015 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | Newly diagnosed glioblastoma with temozolomide (EF-14) source |
| 2 Oct 2015 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | PD-L1+ NSCLC after platinum source |
| 1 Oct 2015 | Nivolumab Monoclonal antibody (anti-PD-1) | Approval | US | With ipilimumab, BRAF wild-type melanoma (CheckMate 067) source |
| Sept 2015 | Trifluridine/tipiracil Cytotoxic chemotherapy (oral nucleoside) | Approval | US | RECOURSE |
| 17 Aug 2015 | Approval | US | Post-transplant consolidation in Hodgkin lymphoma (AETHERA) source | |
| 10 Mar 2015 | Dinutuximab (ch14.18) / dinutuximab beta Monoclonal antibody (anti-GD2, chimeric) | Approval | US | Unituxin (ANBL0032) |
| 4 Mar 2015 | Nivolumab Monoclonal antibody (anti-PD-1) | Approval | US | Squamous NSCLC after platinum: first PD-1 in lung cancer source |
| 3 Feb 2015 | Palbociclib Small-molecule CDK4/6 inhibitor | Approval | US | Accelerated approval with letrozole: first CDK4/6 inhibitor (PALOMA-1) source |
| 22 Dec 2014 | Nivolumab Monoclonal antibody (anti-PD-1) | Approval | US | Advanced melanoma after ipilimumab (accelerated) source |
| 19 Dec 2014 | Olaparib Small-molecule PARP inhibitor | Approval | US | gBRCA advanced ovarian cancer after ≥3 lines: first PARP inhibitor source |
| 10 Dec 2014 | Nonavalent HPV vaccine Prophylactic vaccine (virus-like particles) | Approval | US | Gardasil 9 approved |
| 3 Dec 2014 | Blinatumomab Bispecific T-cell engager (CD19×CD3) | Approval | US | Accelerated approval, Ph-negative relapsed/refractory B-ALL: first BiTE source |
| 4 Sept 2014 | Pembrolizumab Monoclonal antibody (anti-PD-1) | Approval | US | Accelerated approval, advanced melanoma after ipilimumab; first PD-1 inhibitor in the US source |
| 14 Aug 2014 | Bevacizumab Monoclonal antibody (anti-VEGF) | Approval | US | Cervical cancer with chemotherapy (GOG-0240) |
| 4 Jul 2014 | Nivolumab Monoclonal antibody (anti-PD-1) | Approval | JP | First PD-1 inhibitor approved worldwide (melanoma, Japan) source |
| May 2014 | Panitumumab Monoclonal antibody (anti-EGFR) | Label change | US | First-line with FOLFOX in RAS wild-type (PRIME) |
| 12 Feb 2014 | Ibrutinib Small-molecule covalent BTK inhibitor (first generation) | Approval | US | Relapsed CLL |
| 13 Nov 2013 | Ibrutinib Small-molecule covalent BTK inhibitor (first generation) | Approval | US | Mantle cell lymphoma (accelerated); first BTK inhibitor |
| 31 Oct 2013 | Ponatinib Small-molecule kinase inhibitor (pan-BCR::ABL1 incl. T315I) | Withdrawal | US | Temporary marketing suspension for arterial occlusion; returned with narrowed label December 2013 |
| 30 Sept 2013 | Pertuzumab Monoclonal antibody (anti-HER2, dimerisation domain) | Approval | US | Neoadjuvant accelerated approval on pCR |
| 6 Sept 2013 | Paclitaxel / nab-paclitaxel Cytotoxic chemotherapy (taxane) | Approval | US | nab-Paclitaxel with gemcitabine for metastatic pancreatic cancer source |
| 22 Feb 2013 | Approval | US | HER2+ metastatic breast cancer after trastuzumab and taxane (EMILIA); first ADC for a solid tumour source | |
| 14 Dec 2012 | Ponatinib Small-molecule kinase inhibitor (pan-BCR::ABL1 incl. T315I) | Approval | US | Resistant CML/Ph+ ALL |
| Jul 2012 | Cetuximab Monoclonal antibody (anti-EGFR) | Label change | US | Label restricted to KRAS wild-type; first-line FOLFIRI indication (CRYSTAL) |
| 8 Jun 2012 | Pertuzumab Monoclonal antibody (anti-HER2, dimerisation domain) | Approval | US | First-line metastatic (CLEOPATRA) |
| 19 Aug 2011 | Approval | US | Accelerated approval, relapsed Hodgkin lymphoma and systemic ALCL source | |
| 17 Aug 2011 | Vemurafenib Small-molecule kinase inhibitor (BRAF V600) | Approval | US | Approved with the cobas BRAF V600 companion test, the first melanoma targeted therapy |
| 8 Apr 2011 | Optune / Optune Pax (TTFields) Device (tumour treating fields) | Approval | US | PMA approval, recurrent glioblastoma source |
| 6 Apr 2011 | Vandetanib Small-molecule kinase inhibitor (RET, VEGFR, EGFR) | Approval | US | First approval for medullary thyroid cancer |
| 25 Mar 2011 | Ipilimumab Monoclonal antibody (anti-CTLA-4) | Approval | US | Metastatic melanoma: first checkpoint inhibitor approved anywhere source |
| 20 Oct 2010 | Trastuzumab Monoclonal antibody (anti-HER2) | Approval | US | HER2+ metastatic gastric cancer (ToGA) source |
| 21 Jun 2010 | Withdrawal | US | Voluntary withdrawal after confirmatory trial showed no benefit and excess deaths source | |
| 19 Dec 2008 | Imatinib Small-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA) | Approval | US | Adjuvant GIST source |
| 16 Nov 2007 | Sorafenib Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, RAF) | Approval | US | Unresectable HCC on SHARP |
| 16 Nov 2006 | Trastuzumab Monoclonal antibody (anti-HER2) | Approval | US | Adjuvant HER2+ early breast cancer (HERA, NSABP B-31/N9831) source |
| Sept 2006 | Panitumumab Monoclonal antibody (anti-EGFR) | Approval | US | Accelerated approval, refractory mCRC |
| 29 Jun 2006 | Lenalidomide Immunomodulatory drug (cereblon E3 ligase modulator) | Approval | US | Myeloma with dexamethasone |
| 8 Jun 2006 | Nonavalent HPV vaccine Prophylactic vaccine (virus-like particles) | Approval | US | Original quadrivalent Gardasil approved |
| 28 Dec 2005 | Letrozole (and other aromatase inhibitors) Small-molecule aromatase inhibitor | Approval | US | Letrozole adjuvant indication |
| 27 Dec 2005 | Lenalidomide Immunomodulatory drug (cereblon E3 ligase modulator) | Approval | US | MDS del(5q) |
| 7 Jan 2005 | Paclitaxel / nab-paclitaxel Cytotoxic chemotherapy (taxane) | Approval | US | nab-Paclitaxel (Abraxane) for metastatic breast cancer source |
| 2004 | Carboplatin Cytotoxic chemotherapy (platinum) | Approval | US | First generics source |
| 19 May 2004 | Azacitidine Small-molecule hypomethylating agent (cytotoxic) | Approval | US | First hypomethylating agent approved (MDS) |
| 26 Feb 2004 | Bevacizumab Monoclonal antibody (anti-VEGF) | Approval | US | First anti-angiogenic approval (colorectal) |
| Feb 2004 | Bevacizumab Monoclonal antibody (anti-VEGF) | Approval | US | First anti-angiogenic approval (AVF2107) |
| Feb 2004 | Cetuximab Monoclonal antibody (anti-EGFR) | Approval | US | Initial approval in EGFR-expressing mCRC (BOND trial) |
| Jan 2004 | Oncotype DX Gene-expression prognostic/predictive assay | Filing / deal | US | Launched as a laboratory-developed test source |
| 1 Feb 2002 | Imatinib Small-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA) | Approval | US | KIT+ gastrointestinal stromal tumour source |
| 10 May 2001 | Imatinib Small-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA) | Approval | US | Chronic myeloid leukaemia: first targeted kinase inhibitor, approved in under 3 months source |
| 17 May 2000 | Approval | US | Accelerated approval, relapsed CD33+ AML in older patients; first ADC ever approved source | |
| 25 Sept 1998 | Trastuzumab Monoclonal antibody (anti-HER2) | Approval | US | HER2+ metastatic breast cancer: first targeted antibody for a solid tumour source |
| 25 Jul 1997 | Letrozole (and other aromatase inhibitors) Small-molecule aromatase inhibitor | Approval | US | Letrozole approved for advanced breast cancer |
| 13 Apr 1994 | Paclitaxel / nab-paclitaxel Cytotoxic chemotherapy (taxane) | Approval | US | Metastatic breast cancer source |
| 29 Dec 1992 | Paclitaxel / nab-paclitaxel Cytotoxic chemotherapy (taxane) | Approval | US | Refractory ovarian cancer source |
| 3 Mar 1989 | Carboplatin Cytotoxic chemotherapy (platinum) | Approval | US | Ovarian cancer source |
| 1946 | Radioactive iodine (I-131) Radiopharmaceutical (beta/gamma emitter, natural uptake) | Approval | US | First therapeutic use in thyroid cancer (Seidlin); formal approval followed |