Designations, filings, approvals, complete response letters, withdrawals and label changes across products; the 100 most recent. https://onco.cc/feeds/regulatory.xml 2026-11-14T00:00:00Z OnCohttps://onco.cc/ Data CC BY 4.0, attribute "OnCo (onco.cc)" OnCo build-feeds https://onco.cc/drugs/ivonescimab/#regulatory-2026-11-14-pdufa 2026-11-14T00:00:00Z

PDUFA target date

<p>PDUFA target date</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/galleri/#regulatory-2026-09-23-advisory-committee 2026-09-23T00:00:00Z

FDA Molecular and Clinical Genetics Panel meeting

<p>FDA Molecular and Clinical Genetics Panel meeting</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/camizestrant/#regulatory-2026-09-04-approval 2026-09-04T00:00:00Z

Accelerated approval (Etcamah)

<p>Accelerated approval (Etcamah)</p><p>Source: <a href="https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment">https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment</a></p> https://onco.cc/drugs/itm-11/#regulatory-2026-08-28-pdufa 2026-08-28T00:00:00Z

PDUFA goal date for GEP-NET indication

<p>PDUFA goal date for GEP-NET indication</p><p>Source: <a href="https://www.cancernetwork.com/view/fda-accepts-new-drug-application-for-177lu-edotreotide-in-gep-nets">https://www.cancernetwork.com/view/fda-accepts-new-drug-application-for-177lu-edotreotide-in-gep-nets</a></p> https://onco.cc/drugs/intismeran-autogene/#regulatory-2026-08-19-filing 2026-08-19T00:00:00Z

Phase 3 INTerpath-001 met RFS and DMFS endpoints; filings to follow

<p>Phase 3 INTerpath-001 met RFS and DMFS endpoints; filings to follow</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/vusolimogene-oderparepvec/#regulatory-2026-08-06-approval 2026-08-06T00:00:00Z

Accelerated approval with nivolumab for unresectable/metastatic melanoma after anti-PD-1 (IGNYTE)

<p>Accelerated approval with nivolumab for unresectable/metastatic melanoma after anti-PD-1 (IGNYTE)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/pluvicto/#regulatory-2026-07-31-approval 2026-07-31T00:00:00Z

PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition)

<p>PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/selinexor/#regulatory-2026-07-30-filing 2026-07-30T00:00:00Z

XPORT-EC-042 misses primary endpoint; endometrial development deprioritised

<p>XPORT-EC-042 misses primary endpoint; endometrial development deprioritised</p><p>Source: <a href="https://cancerletter.com/clinical-roundup/20260807_8a/">https://cancerletter.com/clinical-roundup/20260807_8a/</a></p> https://onco.cc/drugs/camrelizumab-rivoceranib/#regulatory-2026-07-23-crl 2026-07-23T00:00:00Z

Third CRL, again cGMP

<p>Third CRL, again cGMP</p><p>Source: <a href="https://www.targetedonc.com/view/fda-passes-again-on-approving-rivoceranib-plus-camrelizumab-in-hcc">https://www.targetedonc.com/view/fda-passes-again-on-approving-rivoceranib-plus-camrelizumab-in-hcc</a></p> https://onco.cc/drugs/gedatolisib/#regulatory-2026-07-15-approval 2026-07-15T00:00:00Z

HR+/HER2- advanced breast cancer after CDK4/6 inhibitor with palbociclib and fulvestrant (VIKTORIA-1)

<p>HR+/HER2- advanced breast cancer after CDK4/6 inhibitor with palbociclib and fulvestrant (VIKTORIA-1)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/isatuximab/#regulatory-2026-07-15-approval 2026-07-15T00:00:00Z

Subcutaneous on-body injector

<p>Subcutaneous on-body injector</p> https://onco.cc/drugs/sacituzumab-tirumotecan/#regulatory-2026-07-15-designation 2026-07-15T00:00:00Z

Commissioner's National Priority Voucher (CNPV) awarded

<p>Commissioner's National Priority Voucher (CNPV) awarded</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/selpercatinib/#regulatory-2026-07-15-label-change 2026-07-15T00:00:00Z

Label update (July 2026 oncology approvals list)

<p>Label update (July 2026 oncology approvals list)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/zidesamtinib/#regulatory-2026-07-15-approval 2026-07-15T00:00:00Z

ROS1+ NSCLC (ARROS-1)

<p>ROS1+ NSCLC (ARROS-1)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/cretostimogene/#regulatory-2026-06-30-filing 2026-06-30T00:00:00Z

Rolling BLA initiated; completion expected Q4 2026

<p>Rolling BLA initiated; completion expected Q4 2026</p><p>Source: <a href="https://cgoncology.com/cg-oncology-reports-first-quarter-2026-financial-results-and-provides-business-updates-2/">https://cgoncology.com/cg-oncology-reports-first-quarter-2026-financial-results-and-provides-business-updates-2/</a></p> https://onco.cc/drugs/fianlimab/#regulatory-2026-06-30-designation 2026-06-30T00:00:00Z

First-line metastatic phase 3 missed its primary PFS endpoint (Regeneron release)

<p>First-line metastatic phase 3 missed its primary PFS endpoint (Regeneron release)</p> https://onco.cc/drugs/afamitresgene-autoleucel/#regulatory-2026-05-15-label-change 2026-05-15T00:00:00Z

Label extended to patients aged 12 and older

<p>Label extended to patients aged 12 and older</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/artera-ai-breast/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer

<p>FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/atezolizumab/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

Adjuvant ctDNA-positive muscle-invasive bladder cancer (IMvigor011): first ctDNA-guided indication

<p>Adjuvant ctDNA-positive muscle-invasive bladder cancer (IMvigor011): first ctDNA-guided indication</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/belzutifan/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

Adjuvant clear-cell RCC with pembrolizumab (LITESPARK-022)

<p>Adjuvant clear-cell RCC with pembrolizumab (LITESPARK-022)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/capivasertib/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

PTEN-deficient metastatic prostate cancer with abiraterone (CAPItello-281)

<p>PTEN-deficient metastatic prostate cancer with abiraterone (CAPItello-281)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/datopotamab-deruxtecan/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible (TROPION-Breast02)

<p>First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible (TROPION-Breast02)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/durvalumab/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC)

<p>High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/palbociclib/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

Maintenance in HR+/HER2+ advanced breast cancer with anti-HER2 and endocrine therapy (PATINA)

<p>Maintenance in HR+/HER2+ advanced breast cancer with anti-HER2 and endocrine therapy (PATINA)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/pembrolizumab/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

Adjuvant RCC with belzutifan; with sacituzumab govitecan in first-line PD-L1+ TNBC

<p>Adjuvant RCC with belzutifan; with sacituzumab govitecan in first-line PD-L1+ TNBC</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/sacituzumab-govitecan/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04)

<p>First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/signatera/#regulatory-2026-05-15-label-change 2026-05-15T00:00:00Z

Used to select ctDNA-positive patients in the first ctDNA-guided drug approval (IMvigor011, atezolizumab)

<p>Used to select ctDNA-positive patients in the first ctDNA-guided drug approval (IMvigor011, atezolizumab)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/trastuzumab-deruxtecan/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

Early-stage HER2+ breast cancer: neoadjuvant (DESTINY-Breast11) and post-neoadjuvant residual disease (DESTINY-Breast05)

<p>Early-stage HER2+ breast cancer: neoadjuvant (DESTINY-Breast11) and post-neoadjuvant residual disease (DESTINY-Breast05)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/trastuzumab-emtansine/#regulatory-2026-05-15-label-change 2026-05-15T00:00:00Z

Displaced post-neoadjuvantly by T-DXd approval (DESTINY-Breast05)

<p>Displaced post-neoadjuvantly by T-DXd approval (DESTINY-Breast05)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/vepdegestrant/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

ESR1-mutated ER+/HER2- advanced breast cancer after endocrine therapy: first PROTAC approved

<p>ESR1-mutated ER+/HER2- advanced breast cancer after endocrine therapy: first PROTAC approved</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/zenocutuzumab/#regulatory-2026-05-15-approval 2026-05-15T00:00:00Z

NRG1-fusion cholangiocarcinoma

<p>NRG1-fusion cholangiocarcinoma</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/decitabine-cedazuridine/#regulatory-2026-05-13-approval 2026-05-13T00:00:00Z

With venetoclax in newly diagnosed unfit AML

<p>With venetoclax in newly diagnosed unfit AML</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute">https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute</a></p> https://onco.cc/drugs/sonrotoclax/#regulatory-2026-05-13-approval 2026-05-13T00:00:00Z

Accelerated approval in MCL; priority review, Project Orbis

<p>Accelerated approval in MCL; priority review, Project Orbis</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma">https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma</a></p> https://onco.cc/drugs/camizestrant/#regulatory-2026-04-30-advisory-committee 2026-04-30T00:00:00Z

ODAC voted 6-3 against (clinical relevance of ctDNA-triggered switch)

<p>ODAC voted 6-3 against (clinical relevance of ctDNA-triggered switch)</p><p>Source: <a href="https://www.cancernetwork.com/view/fda-odac-no-camizestrant-for-hr-her2-esr1-advanced-breast-cancer">https://www.cancernetwork.com/view/fda-odac-no-camizestrant-for-hr-her2-esr1-advanced-breast-cancer</a></p> https://onco.cc/drugs/nivolumab/#regulatory-2026-03-15-approval 2026-03-15T00:00:00Z

First-line advanced classical Hodgkin lymphoma with AVD, age ≥12 (SWOG S1826)

<p>First-line advanced classical Hodgkin lymphoma with AVD, age ≥12 (SWOG S1826)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/tafasitamab/#regulatory-2026-03-15-filing 2026-03-15T00:00:00Z

sBLA for frontline high-risk DLBCL (frontMIND) planned H1 2026

<p>sBLA for frontline high-risk DLBCL (frontMIND) planned H1 2026</p><p>Source: <a href="https://www.onclive.com/view/frontmind-results-tafasitamab-based-combo-yields-significant-pfs-benefit-over-r-chop-in-frontline-high-risk-dlbcl">https://www.onclive.com/view/frontmind-results-tafasitamab-based-combo-yields-significant-pfs-benefit-over-r-chop-in-frontline-high-risk-dlbcl</a></p> https://onco.cc/drugs/tazemetostat/#regulatory-2026-03-15-withdrawal 2026-03-15T00:00:00Z

Withdrawn over secondary haematologic malignancies

<p>Withdrawn over secondary haematologic malignancies</p> https://onco.cc/drugs/zelenectide-pevedotin/#regulatory-2026-03-15-withdrawal 2026-03-15T00:00:00Z

Programme deprioritised after regulatory feedback on Duravelo-2 design

<p>Programme deprioritised after regulatory feedback on Duravelo-2 design</p><p>Source: <a href="https://www.oncologypipeline.com/apexonco/bicycle-finally-falls">https://www.oncologypipeline.com/apexonco/bicycle-finally-falls</a></p> https://onco.cc/drugs/giredestrant/#regulatory-2026-03-09-designation 2026-03-09T00:00:00Z

persevERA primary endpoint not met

<p>persevERA primary endpoint not met</p><p>Source: <a href="https://www.roche.com/media/releases/med-cor-2026-03-09">https://www.roche.com/media/releases/med-cor-2026-03-09</a></p> https://onco.cc/drugs/pylarify/#regulatory-2026-03-09-approval 2026-03-09T00:00:00Z

Pylarify TruVu formulation

<p>Pylarify TruVu formulation</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/daratumumab/#regulatory-2026-03-05-approval 2026-03-05T00:00:00Z

Teclistamab + daratumumab after ≥1 prior line

<p>Teclistamab + daratumumab after ≥1 prior line</p><p>Source: <a href="https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-tecvayli-plus-darzalex-faspro-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care-as-early-as-second-line">https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-tecvayli-plus-darzalex-faspro-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care-as-early-as-second-line</a></p> https://onco.cc/drugs/izalontamab-brengitecan/#regulatory-2026-02-26-filing 2026-02-26T00:00:00Z

Positive interim phase 3 in pretreated TNBC (BL-B01D1-307) announced; regulatory submissions follow

<p>Positive interim phase 3 in pretreated TNBC (BL-B01D1-307) announced; regulatory submissions follow</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/acalabrutinib/#regulatory-2026-02-19-approval 2026-02-19T00:00:00Z

Acalabrutinib + venetoclax fixed duration (AMPLIFY)

<p>Acalabrutinib + venetoclax fixed duration (AMPLIFY)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma">https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma</a></p> https://onco.cc/drugs/giredestrant/#regulatory-2026-02-19-filing 2026-02-19T00:00:00Z

NDA accepted (evERA, ESR1-mutant)

<p>NDA accepted (evERA, ESR1-mutant)</p><p>Source: <a href="https://www.gene.com/media/press-releases/15100/2026-02-19/fda-accepts-new-drug-application-for-gen">https://www.gene.com/media/press-releases/15100/2026-02-19/fda-accepts-new-drug-application-for-gen</a></p> https://onco.cc/drugs/anitocabtagene-autoleucel/#regulatory-2026-02-15-filing 2026-02-15T00:00:00Z

BLA accepted; PDUFA 27 December 2026

<p>BLA accepted; PDUFA 27 December 2026</p><p>Source: <a href="https://allsci.com/news/earnings-call-insights/gileads-q126-earnings-call-anito-cel-poised-for-december-pdufa-decision-three-acquisitions-near-inflection-points/">https://allsci.com/news/earnings-call-insights/gileads-q126-earnings-call-anito-cel-poised-for-december-pdufa-decision-three-acquisitions-near-inflection-points/</a></p> https://onco.cc/drugs/atirmociclib/#regulatory-2026-02-15-designation 2026-02-15T00:00:00Z

Positive topline phase 2 FOURLIGHT-1

<p>Positive topline phase 2 FOURLIGHT-1</p><p>Source: <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-2-results-next">https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-2-results-next</a></p> https://onco.cc/drugs/encorafenib/#regulatory-2026-02-15-approval 2026-02-15T00:00:00Z

Full approval in first-line BRAF V600E mCRC with OS benefit

<p>Full approval in first-line BRAF V600E mCRC with OS benefit</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/optune/#regulatory-2026-02-15-approval 2026-02-15T00:00:00Z

Optune Pax, locally advanced pancreatic cancer with chemotherapy (PANOVA-3)

<p>Optune Pax, locally advanced pancreatic cancer with chemotherapy (PANOVA-3)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/pembrolizumab/#regulatory-2026-02-15-approval 2026-02-15T00:00:00Z

Platinum-resistant PD-L1+ ovarian cancer

<p>Platinum-resistant PD-L1+ ovarian cancer</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/relacorilant/#regulatory-2026-02-15-approval 2026-02-15T00:00:00Z

Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer with nab-paclitaxel

<p>Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer with nab-paclitaxel</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/teclistamab/#regulatory-2026-02-15-approval 2026-02-15T00:00:00Z

Relapsed/refractory myeloma after ≥1 prior line, with daratumumab (MajesTEC-3)

<p>Relapsed/refractory myeloma after ≥1 prior line, with daratumumab (MajesTEC-3)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/zongertinib/#regulatory-2026-02-15-approval 2026-02-15T00:00:00Z

First-line HER2-mutant non-squamous NSCLC

<p>First-line HER2-mutant non-squamous NSCLC</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/camrelizumab-rivoceranib/#regulatory-2026-01-30-filing 2026-01-30T00:00:00Z

Resubmission accepted; PDUFA 23 July 2026

<p>Resubmission accepted; PDUFA 23 July 2026</p><p>Source: <a href="https://www.globenewswire.com/news-release/2026/01/30/3229623/0/en/elevar-therapeutics-announces-fda-acceptance-of-new-drug-application-resubmission-for-rivoceranib-in-combination-with-camrelizumab-as-a-first-line-systemic-treatment-for-unresectab.html">https://www.globenewswire.com/news-release/2026/01/30/3229623/0/en/elevar-therapeutics-announces-fda-acceptance-of-new-drug-application-resubmission-for-rivoceranib-in-combination-with-camrelizumab-as-a-first-line-systemic-treatment-for-unresectab.html</a></p> https://onco.cc/drugs/galleri/#regulatory-2026-01-29-filing 2026-01-29T00:00:00Z

Final PMA module submitted

<p>Final PMA module submitted</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/epcoritamab/#regulatory-2026-01-16-filing 2026-01-16T00:00:00Z

EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met

<p>EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met</p><p>Source: <a href="https://news.abbvie.com/2026-01-16-AbbVie-Announces-Topline-Results-for-Epcoritamab-DuoBody-R-CD3xCD20-from-Phase-3-EPCORE-R-DLBCL-1-Trial-in-Patients-with-Relapsed-Refractory-Diffuse-Large-B-cell-Lymphoma-DLBCL">https://news.abbvie.com/2026-01-16-AbbVie-Announces-Topline-Results-for-Epcoritamab-DuoBody-R-CD3xCD20-from-Phase-3-EPCORE-R-DLBCL-1-Trial-in-Patients-with-Relapsed-Refractory-Diffuse-Large-B-cell-Lymphoma-DLBCL</a></p> https://onco.cc/drugs/ivonescimab/#regulatory-2026-01-15-filing 2026-01-15T00:00:00Z

BLA submitted by Summit for EGFR-mutant NSCLC after TKI (HARMONi)

<p>BLA submitted by Summit for EGFR-mutant NSCLC after TKI (HARMONi)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/daraxonrasib/#regulatory-2025-12-15-filing 2025-12-15T00:00:00Z

RASolute 302 phase 3 fully enrolled; topline 2026

<p>RASolute 302 phase 3 fully enrolled; topline 2026</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/disitamab-vedotin/#regulatory-2025-12-15-filing 2025-12-15T00:00:00Z

First-line urothelial cancer with toripalimab, positive phase 3

<p>First-line urothelial cancer with toripalimab, positive phase 3</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/tarlatamab/#regulatory-2025-12-15-approval 2025-12-15T00:00:00Z

Full approval based on DeLLphi-304

<p>Full approval based on DeLLphi-304</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/zanidatamab/#regulatory-2025-12-15-filing 2025-12-15T00:00:00Z

First-line HER2+ gastro-oesophageal adenocarcinoma (HERIZON-GEA-01) submission

<p>First-line HER2+ gastro-oesophageal adenocarcinoma (HERIZON-GEA-01) submission</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/pirtobrutinib/#regulatory-2025-12-03-approval 2025-12-03T00:00:00Z

Traditional approval; label broadened to any prior covalent BTKi

<p>Traditional approval; label broadened to any prior covalent BTKi</p><p>Source: <a href="https://ascopost.com/news/december-2025/fda-grants-traditional-approval-to-pirtobrutinib-for-cllsll/">https://ascopost.com/news/december-2025/fda-grants-traditional-approval-to-pirtobrutinib-for-cllsll/</a></p> https://onco.cc/drugs/durvalumab/#regulatory-2025-11-15-approval 2025-11-15T00:00:00Z

Perioperative gastric/GEJ cancer with FLOT (MATTERHORN)

<p>Perioperative gastric/GEJ cancer with FLOT (MATTERHORN)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/enfortumab-vedotin/#regulatory-2025-11-15-filing 2025-11-15T00:00:00Z

Muscle-invasive bladder cancer (EV-303/304) submissions following positive results

<p>Muscle-invasive bladder cancer (EV-303/304) submissions following positive results</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/ziftomenib/#regulatory-2025-11-13-approval 2025-11-13T00:00:00Z

KOMET-001; priority review

<p>KOMET-001; priority review</p><p>Source: <a href="https://ascopost.com/news/november-2025/fda-approves-ziftomenib-for-npm1-positive-aml/">https://ascopost.com/news/november-2025/fda-approves-ziftomenib-for-npm1-positive-aml/</a></p> https://onco.cc/drugs/belantamab-mafodotin/#regulatory-2025-10-15-approval 2025-10-15T00:00:00Z

Approval in combination regimens for relapsed/refractory myeloma after ≥1 line (DREAMM-7/8)

<p>Approval in combination regimens for relapsed/refractory myeloma after ≥1 line (DREAMM-7/8)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/cemiplimab/#regulatory-2025-10-15-approval 2025-10-15T00:00:00Z

Adjuvant high-risk CSCC after surgery and radiation (C-POST)

<p>Adjuvant high-risk CSCC after surgery and radiation (C-POST)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/revumenib/#regulatory-2025-10-15-approval 2025-10-15T00:00:00Z

Relapsed/refractory NPM1-mutant AML

<p>Relapsed/refractory NPM1-mutant AML</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/lurbinectedin/#regulatory-2025-10-02-approval 2025-10-02T00:00:00Z

Full approval with atezolizumab as first-line maintenance (IMforte)

<p>Full approval with atezolizumab as first-line maintenance (IMforte)</p><p>Source: <a href="https://www.roche.com/media/releases/med-cor-2025-10-03b">https://www.roche.com/media/releases/med-cor-2025-10-03b</a></p> https://onco.cc/drugs/imlunestrant/#regulatory-2025-09-25-approval 2025-09-25T00:00:00Z

Approved as Inluriyo

<p>Approved as Inluriyo</p><p>Source: <a href="https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1">https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1</a></p> https://onco.cc/drugs/amivantamab/#regulatory-2025-09-15-approval 2025-09-15T00:00:00Z

Subcutaneous formulation (PALOMA-3)

<p>Subcutaneous formulation (PALOMA-3)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/pembrolizumab/#regulatory-2025-09-15-approval 2025-09-15T00:00:00Z

Subcutaneous pembrolizumab (Keytruda Qlex)

<p>Subcutaneous pembrolizumab (Keytruda Qlex)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/satricabtagene-autoleucel/#regulatory-2025-09-15-approval 2025-09-15T00:00:00Z

First CAR-T approved for a solid tumour (CLDN18.2+ gastric/GEJ adenocarcinoma)

<p>First CAR-T approved for a solid tumour (CLDN18.2+ gastric/GEJ adenocarcinoma)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/tar-200/#regulatory-2025-09-09-approval 2025-09-09T00:00:00Z

FDA approval of Inlexzo

<p>FDA approval of Inlexzo</p><p>Source: <a href="https://www.onclive.com/view/fda-approves-tar-200-in-bcg-unresponsive-nmibc-with-cis">https://www.onclive.com/view/fda-approves-tar-200-in-bcg-unresponsive-nmibc-with-cis</a></p> https://onco.cc/drugs/afamitresgene-autoleucel/#regulatory-2025-08-15-filing 2025-08-15T00:00:00Z

US rights sold by Adaptimmune to US WorldMeds

<p>US rights sold by Adaptimmune to US WorldMeds</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/artera-ai-prostate/#regulatory-2025-08-14-approval 2025-08-14T00:00:00Z

De novo authorisation: first AI pathology test cleared for prognostic and predictive use in localised prostate cancer

<p>De novo authorisation: first AI pathology test cleared for prognostic and predictive use in localised prostate cancer</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/zongertinib/#regulatory-2025-08-08-approval 2025-08-08T00:00:00Z

Accelerated approval, previously treated HER2-mutant non-squamous NSCLC (Beamion LUNG-1)

<p>Accelerated approval, previously treated HER2-mutant non-squamous NSCLC (Beamion LUNG-1)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/letetresgene-autoleucel/#regulatory-2025-08-04-filing 2025-08-04T00:00:00Z

Asset transferred to US WorldMeds; BLA committed by end-2026

<p>Asset transferred to US WorldMeds; BLA committed by end-2026</p> https://onco.cc/drugs/odronextamab/#regulatory-2025-07-30-approval 2025-07-30T00:00:00Z

Accelerated approval in follicular lymphoma

<p>Accelerated approval in follicular lymphoma</p> https://onco.cc/drugs/belantamab-mafodotin/#regulatory-2025-07-23-crl 2025-07-23T00:00:00Z

Complete response letter on combination filing; resubmitted

<p>Complete response letter on combination filing; resubmitted</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/vusolimogene-oderparepvec/#regulatory-2025-07-22-crl 2025-07-22T00:00:00Z

Complete response letter citing trial design and heterogeneity

<p>Complete response letter citing trial design and heterogeneity</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/glofitamab/#regulatory-2025-07-02-crl 2025-07-02T00:00:00Z

Complete response letter for STARGLO combination (regional heterogeneity); approved in EU

<p>Complete response letter for STARGLO combination (regional heterogeneity); approved in EU</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/linvoseltamab/#regulatory-2025-07-02-approval 2025-07-02T00:00:00Z

Accelerated approval (LINKER-MM1)

<p>Accelerated approval (LINKER-MM1)</p><p>Source: <a href="https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval">https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval</a></p> https://onco.cc/drugs/eflornithine/#regulatory-2025-06-30-filing 2025-06-30T00:00:00Z

MAA submitted to EMA, UK, Australia, Switzerland

<p>MAA submitted to EMA, UK, Australia, Switzerland</p><p>Source: <a href="https://www.onclive.com/view/eu-approval-is-sought-for-eflornithine-in-high-risk-neuroblastoma">https://www.onclive.com/view/eu-approval-is-sought-for-eflornithine-in-high-risk-neuroblastoma</a></p> https://onco.cc/drugs/nirogacestat/#regulatory-2025-06-30-approval 2025-06-30T00:00:00Z

European Commission approval

<p>European Commission approval</p><p>Source: <a href="https://www.onclive.com/view/nirogacestat-wins-eu-approval-for-progressing-desmoid-tumors">https://www.onclive.com/view/nirogacestat-wins-eu-approval-for-progressing-desmoid-tumors</a></p> https://onco.cc/drugs/rinatabart-sesutecan/#regulatory-2025-06-30-designation 2025-06-30T00:00:00Z

Breakthrough Therapy designation, advanced endometrial cancer after PD-(L)1 and platinum

<p>Breakthrough Therapy designation, advanced endometrial cancer after PD-(L)1 and platinum</p><p>Source: <a href="https://www.cancernetwork.com/view/rina-s-earns-fda-breakthrough-therapy-designation-in-endometrial-cancer">https://www.cancernetwork.com/view/rina-s-earns-fda-breakthrough-therapy-designation-in-endometrial-cancer</a></p> https://onco.cc/drugs/serplulimab/#regulatory-2025-06-30-approval 2025-06-30T00:00:00Z

MHRA approval

<p>MHRA approval</p><p>Source: <a href="https://www.henlius.com/en/NewsDetails-5324-26.html">https://www.henlius.com/en/NewsDetails-5324-26.html</a></p> https://onco.cc/drugs/tisagenlecleucel/#regulatory-2025-06-27-label-change 2025-06-27T00:00:00Z

REMS requirements removed for approved CAR-T products

<p>REMS requirements removed for approved CAR-T products</p> https://onco.cc/drugs/datopotamab-deruxtecan/#regulatory-2025-06-23-approval 2025-06-23T00:00:00Z

EGFR-mutant NSCLC after TKI and platinum chemotherapy (accelerated)

<p>EGFR-mutant NSCLC after TKI and platinum chemotherapy (accelerated)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/adagrasib/#regulatory-2025-06-15-approval 2025-06-15T00:00:00Z

Full approval in NSCLC (KRYSTAL-12)

<p>Full approval in NSCLC (KRYSTAL-12)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/ciltacabtagene-autoleucel/#regulatory-2025-06-15-label-change 2025-06-15T00:00:00Z

REMS requirements removed for CAR-T class

<p>REMS requirements removed for CAR-T class</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/dostarlimab/#regulatory-2025-06-15-designation 2025-06-15T00:00:00Z

Breakthrough Therapy designation, dMMR locally advanced rectal cancer (organ preservation)

<p>Breakthrough Therapy designation, dMMR locally advanced rectal cancer (organ preservation)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/inavolisib/#regulatory-2025-06-15-label-change 2025-06-15T00:00:00Z

OS benefit added to label

<p>OS benefit added to label</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/lifileucel/#regulatory-2025-06-15-approval 2025-06-15T00:00:00Z

Conditional marketing authorisation

<p>Conditional marketing authorisation</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/relacorilant/#regulatory-2025-06-15-filing 2025-06-15T00:00:00Z

NDA submitted (ROSELLA)

<p>NDA submitted (ROSELLA)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/shield/#regulatory-2025-06-15-designation 2025-06-15T00:00:00Z

Breakthrough Device designation for Shield multi-cancer (MCD)

<p>Breakthrough Device designation for Shield multi-cancer (MCD)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/tarlatamab/#regulatory-2025-06-15-filing 2025-06-15T00:00:00Z

Phase 3 DeLLphi-304 OS benefit presented; conversion to full approval pursued

<p>Phase 3 DeLLphi-304 OS benefit presented; conversion to full approval pursued</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/vepdegestrant/#regulatory-2025-06-15-filing 2025-06-15T00:00:00Z

NDA submitted (VERITAC-2)

<p>NDA submitted (VERITAC-2)</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/vorasidenib/#regulatory-2025-06-15-approval 2025-06-15T00:00:00Z

EMA approval

<p>EMA approval</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p> https://onco.cc/drugs/camizestrant/#regulatory-2025-06-01-filing 2025-06-01T00:00:00Z

NDA based on SERENA-6

<p>NDA based on SERENA-6</p> https://onco.cc/drugs/belzutifan/#regulatory-2025-05-15-approval 2025-05-15T00:00:00Z

Pheochromocytoma/paraganglioma

<p>Pheochromocytoma/paraganglioma</p><p>Source: <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications">https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications</a></p>