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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.
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.
ATP-competitive inhibitor of BRAF V600E, V600K and V600D kinases (and wild-type BRAF and CRAF at higher concentrations); blocks MAPK signalling in BRAF-mutant tumours. Connects to BRAF.
1.Dabrafenib slips into a pocket on BRAF.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
Confirmed: the accelerated approval of 2014 converted to traditional approval 1.9 years after it was granted.
In combination with trametinib for adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. *
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.2 years later, when the FDA's table was read. source
| 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 |
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BRAF V600E testing is mandatory in childhood high-grade glioma and the combination is a standard at relapse and, increasingly, alongside or before radiotherapy in newly diagnosed disease; it supported the tumour-agnostic approval in children.
Immunotherapy first is the standard for BRAF-mutant advanced melanoma in patients who can wait for a response; targeted therapy is reserved for rapid control or after immunotherapy.
Rapid BRAF testing is mandatory at diagnosis of anaplastic thyroid cancer, and BRAF-MEK inhibition, increasingly with pembrolizumab and as neoadjuvant therapy, is the standard for BRAF-mutant disease.
Adjuvant dabrafenib-trametinib is a standard for resected stage III BRAF-mutant melanoma alongside adjuvant PD-1 blockade; the choice weighs a finite year of oral therapy against immune side effects.
BRAF plus MEK inhibition is a standard first-line option for BRAF V600E lung cancer, with chemo-immunotherapy as the alternative or subsequent line.
BRAF V600E is a routinely tested lung cancer driver, and BRAF plus MEK inhibition is the standard targeted therapy for it.
BRAF plus MEK inhibitor doublets replaced BRAF monotherapy, and dabrafenib-trametinib became the reference regimen for BRAF-mutant melanoma, later extended to adjuvant use in COMBI-AD.
Query 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.
Shares COMBI-d, Melanoma (KEGG map), Thyroid cancer (KEGG map), Paediatric high-grade glioma (excluding diffuse midline glioma).
Shares COMBI-d, NCI-MATCH (EAY131), Dabrafenib + trametinib, BRAF V600-mutant melanoma.
Shares Melanoma (KEGG map), BRAF V600E (and V600K), BRAF V600E-mutant non-small-cell lung cancer, NCI-MATCH (EAY131).
Shares BRF113928 cohort C (dabrafenib with trametinib, untreated BRAF V600E), BRAF V600E-mutant non-small-cell lung cancer, Dabrafenib + trametinib, BRAF.
Shares COMBI-AD, COMBI-d, BRAF V600-mutant melanoma, Stage III melanoma (after surgery).
Shares BRF113928 cohort C (dabrafenib with trametinib, untreated BRAF V600E), BRAF V600E (and V600K), BRAF V600E-mutant non-small-cell lung cancer, BRAF V600-mutant melanoma.
Shares Basket trial, Thyroid cancer (KEGG map), Papillary thyroid cancer, NCI-MATCH (EAY131).
Shares Optic pathway glioma, Glioma (KEGG map), Paediatric low-grade glioma, Brain and spinal cord tumours (all types).