Drug · Small Molecule

Dabrafenib

CI-DRUG-00000172Explore in graph →NCIt C82386 CHEMBL2028663 CIViC Approved

Regulatory

Approvals (32)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	High-Grade Glioma, NOS	Low-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.	approved	Nov 15, 2023	ema
EU EMA	—	Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).	approved	Aug 26, 2013	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 21 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	34	14	11	113	32	CA, EU, US	May 29, 2013	Jun 4, 2009
Malignant Thyroid Gland Neoplasm	Approved	Phase 3	8	3	2	12	2	US	May 29, 2013	2012-07
Malignant Lung Neoplasm	Approved	Phase 4	3	2	1	5	2	US	May 29, 2013	Aug 17, 2015
Malignant Central Nervous System Neoplasm	Phase4	Phase 4	2	0	0

Curated evidence

Clinical evidence (107)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 51–100 of 107 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
BRAF V600E17
Dabrafenib	Melanoma

Clinical trials

Trials with this intervention (123)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–123 of 123 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01907802	Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction	terminated	Phase 1	8	National Cancer Institute (NCI)NIH	2	Aug 14, 2018	clinicaltrials
NCT02672358	Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC	withdrawn

Molecule

Record

Kind: Small Molecule
Mechanism: Serine/threonine-protein kinase B-raf inhibitor
Targets: 1 gene
UNII: B6DC89I63E
Aliases: Benzenesulfonamide, N-(3-(5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-4-thiazolyl)-2-fluorophenyl)-2,6-difluoro-, BRAF Inhibitor GSK2118436, Dabrafenib, Dabrafenib Mesylate, Finlee, GSK 2118436, GSK-2118436, GSK2118436, GSK 2118436A, GSK-2118436A, GSK2118436A, TAFINLAR

Data updated 29 minutes agoSource updated unknown

Identifiers

Codes (9)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EC02	DABRAFENIB
DIN (Health Canada)	02409607	TAFINLAR

BRAF V600K6
Dabrafenib	Melanoma	Predictive	B	Supports Sensitivity Response	—	accepted	EID2505 Patients were treated with a specific RAF inhibitor (dabrafenib), which improved overall survival of patients with BRAF mutations (P<0.003), compared to non-treated patients with BRAF mutations. Patie… (full text at CIViC) PMID 21343559 · Long et al., 2011 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	—	submitted	EID2507 Proposed resistance mechanisms include PDGFRB upregulation or NRAS mutations resulting in MAPK pathway reactivation, but not secondary mutations in BRAF. MEK inhibitors may demonstrate clinical benefi… (full text at CIViC) PMID 21107323 · Nazarian et al., 2010 · Open in CIViC	civic
Dabrafenib + TrametinibCombination	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID6179 Adjuvant dual treatment with BRAF inhibitor dabrafenib and MEK inhibitor trametinib was administered to patients with stage III resected melenoma with V600E or V600K mutation in this stage III trial (… (full text at CIViC) PMID 28891408 · Long et al., 2017 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID6939 In this Phase III trial (NCT01584648 COMBI-d), previously untreated patients with unrescectable stage IIIC or IV melanoma with BRAF V600E (359 patients) or V600K (61 patients) received dabrafenib and … (full text at CIViC) PMID 25265492 · Long et al., 2014 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID6941 In this Phase I and II study (NCT01072175), patients with metastatic melanoma were treated with either a combination of dabrafenib and trametinib or dabrafenib monotherapy. Among patients with the V60… (full text at CIViC) PMID 23020132 · Flaherty et al., 2012 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID6965 In this Phase III trial (coBRIM, NCT01689519) of 495 V600 mutant melanoma patients, 56 had V600K mutation. 32 patients were treated with vemurafenib and placebo, and 24 were treated with vemurafenib a… (full text at CIViC) PMID 25265494 · Larkin et al., 2014 · Open in CIViC	civic

MAP2K2 C125S2
Dabrafenib + TrametinibCombination	Melanoma	Predictive	C	Supports Resistance	4	submitted	EID7676 In a retrospective study, authors analyzed BRAF V600 mutated melanoma metastases derived from 10 patients treated with the combination of dabrafenib and trametinib for resistance mechanisms and geneti… (full text at CIViC) PMID 25452114 · Long et al., 2014 · Open in CIViC	civic
Dabrafenib + VemurafenibSubstitutes	Melanoma	Predictive	D	Supports Resistance	4	accepted	EID7664 In a retrospective study, resistance mechanisms to BRAF inhibitor such as vemurafenib or dabrafenib in patients with BRAF V600 mutated melanoma were evaluated. Four mutations involving the MAP2K2 gene… (full text at CIViC) PMID 24265153 · Van Allen et al., 2014 · Open in CIViC	civic

RAC1 P29S2
Dabrafenib + VemurafenibSubstitutes	Melanoma	Predictive	B	Supports Resistance	3	submitted	EID7669 In a retrospective study, resistance mechanisms to BRAF inhibitor such as vemurafenib or dabrafenib in patients with BRAF V600 mutated melanoma were evaluated. Among the 14 patients exhibiting early d… (full text at CIViC) PMID 24265153 · Van Allen et al., 2014 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Resistance	4	accepted	EID873 Melanoma cell lines harboring the RAC1 P29S hotspot mutation were shown to be resistant to BRAF inhibition with vemurafenib or dabrafenib and knock-in or knock-out of this mutation decreased and incre… (full text at CIViC) PMID 25056119 · Watson et al., 2014 · Open in CIViC	civic