Dabrafenib
Dabrafenib (Tafinlar) is a capsule that switches off the faulty BRAF protein driving some melanomas, lung, thyroid and other cancers. It is almost always paired with trametinib.
Overview
Dabrafenib was approved by the FDA in May 2013 as a single agent for unresectable or metastatic BRAF V600E melanoma (BREAK-3: progression-free survival superior to dacarbazine) and in 2014 in combination with trametinib, which became the standard after COMBI-d and COMBI-v showed longer overall survival than single-agent BRAF inhibition. Later indications, all with trametinib: adjuvant stage III BRAF-mutant melanoma (COMBI-AD, 2018), BRAF V600E metastatic NSCLC (2017), anaplastic thyroid cancer (2018), tumour-agnostic BRAF V600E solid tumours (2022) and paediatric low-grade glioma with a dispersible tablet formulation (2023). The EU authorised Tafinlar in 2013. Pyrexia is the signature toxicity of the combination; cutaneous squamous cell carcinomas and hyperglycaemia occur with monotherapy.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas: how tumours escape and what closes the route · Lines of therapy.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2013 | BRAF V600E unresectable or metastatic melanoma (single agent) |
| US | 2014 | With trametinib: BRAF V600E/K metastatic melanoma; later adjuvant melanoma, BRAF V600E NSCLC, anaplastic thyroid cancer, tumour-agnostic solid tumours and paediatric low-grade glioma |
| EU | 2013 | BRAF V600 melanoma; later NSCLC and adjuvant melanoma with trametinib |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Dabrafenib" OR ABSTRACT:"Dabrafenib" OR TITLE:"Tafinlar" OR ABSTRACT:"Tafinlar") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Dabrafenib, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductSelumetinib
Shares Trametinib, RAS / RAF / MEK / ERK (MAPK), Small-molecule kinase inhibitors and the tag nci-list.
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Shares Small-molecule kinase inhibitors and the tag nci-list.
- ProductNecitumumab
Shares Non-small-cell lung cancer and the tag nci-list.
- PairingBRAF inhibitor + MEK inhibitor
Shares Dabrafenib + trametinib, BRAF, RAS / RAF / MEK / ERK (MAPK), Melanoma.
- TargetMEK1/2
Shares Trametinib, Thyroid cancer, RAS / RAF / MEK / ERK (MAPK), Melanoma.
- ProductDacarbazine
Shares Melanoma and the tag nci-list.