Drug · Small Molecule

Vemurafenib

CI-DRUG-00000635Explore in graph →NCIt C64768 CHEMBL1229517 CIViC Approved

Regulatory

Approvals (9)

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

health-canada-dpdRegulatory9 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ZELBORAF (DIN 02380242) under ATC L01EC01 VEMURAFENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 5, 2012	health-canada-dpd
EU EMA	Melanoma	Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.	approved	Feb 17, 2012	ema
US FDA	—	Efficacy supplement 2017-11-06 (see label)	approved	Nov 6, 2017	openfda
US FDA	—	Efficacy supplement 2017-09-13 (see label)

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 9 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	18	7	11	116	9	CA, EU, US	Aug 17, 2011	2006-11
Malignant Thyroid Gland Neoplasm	Phase3	Phase 3	4	2	1	7	0	—	—	Nov 7, 2012
Non-Hodgkin Lymphoma	Phase3	Phase 3	4	2	1	8	0	—	—	Apr 12, 2012
Malignant Lung Neoplasm	Phase3	Phase 3	3	2	2	5	0

Curated evidence

Clinical evidence (261)

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

civicCuratedShowing 201–250 of 261 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
MAP2K2 L46F1
Dabrafenib + Vemurafenib

Clinical trials

Trials with this intervention (119)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 119 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
NCT01709292	Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer	active not recruiting	Phase 2	24	M.D. Anderson Cancer CenterOTHER	1	Sep 14, 2026	clinicaltrials
NCT04302025	A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)(NAUTIKA1)

Molecule

Record

Kind: Small Molecule
Mechanism: Serine/threonine-protein kinase B-raf inhibitor
Targets: 1 gene
UNII: 207SMY3FQT
Aliases: 1-propanesulfonamide, N-(3-((5-(4-chlorophenyl)-1h-pyrrolo(2,3-b)pyridin-3-yl)carbonyl)-2,4-difluorophenyl)-, BRAF (V600E) Kinase Inhibitor RO5185426, PLX 4032, PLX-4032, PLX4032, RG 7204, RG7204, RO 5185426, RO-51-85426, Vemurafenib, Zelboraf

Data updated 12 hours agoSource updated unknown

Identifiers

Codes (4)

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

System	Code	Label
ATC (WHO)	L01EC01	VEMURAFENIB
DIN (Health Canada)	02380242	ZELBORAF
DPD drug code

NRAS G13R2
Vemurafenib	Melanoma	Predictive	C	Supports Resistance	—	submitted	EID3843 In a retrospective study of 30 metastatic melanoma patients, a patient harboring NRAS G13R mutation was reported to be resistant to vemurafenib treatment. The patient was initially found to harbor a B… (full text at CIViC) PMID 24463458 · Rizos et al., 2014 · Open in CIViC	civic
〃	Melanoma	Predictive	C	Supports Resistance	—	submitted	EID3844 In a retrospective study of 44 malignant melanoma patients, NRAS G13R was associated with acquired resistance to vemurafenib monotherapy in one patient with disease progressive tumors harboring NRAS G… (full text at CIViC) PMID 24265155 · Shi et al., 2014 · Open in CIViC	civic

NRAS Q61K4
Vemurafenib	Melanoma	Predictive	C	Supports Resistance	4	submitted	EID2191 In 11 melanoma patients harboring BRAF mutations, one patient with a Q61K NRAS mutation acquired resistance to the BRAF inhibitor vemurafenib. Q61K and/or A146T NRAS mutations have also shown resistan… (full text at CIViC) PMID 21107323 · Nazarian et al., 2010 · Open in CIViC	civic
〃	Melanoma	Predictive	C	Supports Resistance	—	submitted	EID3835 In a retrospective study of 44 malignant melanoma patients, NRAS Q61K was associated with acquired resistance to vemurafenib monotherapy in two patients with disease progressive tumors harboring NRAS … (full text at CIViC) PMID 24265155 · Shi et al., 2014 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Resistance	—	submitted	EID3836 In an in vitro study, a M249 cell line expressing BRAF V600E (a known sensitizing mutation to vemurafenib) and NRAS Q61K co-mutations, demonstrated resistance to vemurafenib treatment (GI50: > 10 �mol… (full text at CIViC) PMID 21107323 · Nazarian et al., 2010 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Resistance	—	submitted	EID3837 In an in vitro study, a M249 R4 cell line expressing BRAF V600E (a known sensitizing mutation to vemurafenib) and NRAS Q61K co-mutations demonstrated acquired resistance to vemurafenib treatment. Resi… (full text at CIViC) PMID 22395615 · Shi et al., 2012 · Open in CIViC	civic

NRAS Q61L2
Vemurafenib	Melanoma	Predictive	C	Supports Resistance	—	submitted	EID3825 In a retrospective study of 44 malignant melanoma patients, NRAS Q61L was associated with acquired resistance to vemurafenib monotherapy in one patient with disease progressive tumors harboring NRAS Q… (full text at CIViC) PMID 24265155 · Shi et al., 2014 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Resistance	—	submitted	EID3826 In an in vitro study, the YULOVY and YUFULO cell lines expressing NRAS Q61L were associated with reduced sensitivity to vemurafenib (PLX4032) treatment, as compared to cells expressing wild-type BRAF.… (full text at CIViC) PMID 20149136 · Halaban et al., 2010 · 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

BRAF V600E8
Vemurafenib	Multiple Myeloma	Predictive	C	Supports Sensitivity Response	3	accepted	EID1698 A 65-year-old man presented with stage II myeloma. He was initially treated with chemotherapy and he received an autologous stem cell transplant. Sequencing of the recurrent tumor harbored BRAF V600E… (full text at CIViC) PMID 24997557 · Sharman et al., 2014 · Open in CIViC	civic
〃	Multiple Myeloma	Predictive	C	Supports Sensitivity Response	2	accepted	EID1699 A 54-year-old man presented with stage II myeloma. He was initially treated with chemotherapy and received an autologous stem cell transplant. Genomic profiling of the bone biopsy revealed BRAF V600… (full text at CIViC) PMID 24997557 · Sharman et al., 2014 · Open in CIViC	civic
〃	Ovarian Serous AdenocarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID3787 A stage 4B, low-grade papillary serous ovarian adenocarcinoma patient, harboring a BRAF V600E mutation was associated with response to vemurafenib monotherapy. The patient was treated with standard ch… (full text at CIViC) PMID 26490654 · Combe et al., 2015 · Open in CIViC	civic
〃	Pilocytic Astrocytoma	Predictive	C	Supports Sensitivity Response	—	submitted	EID3772 A pediatric pilocytic astrocytoma patient harboring BRAF V600E mutation, BRAF V600E mutation was associated with response to vemurafenib monotherapy. The patient was treated with standard chemotherapy… (full text at CIViC) PMID 24821190 · Skrypek et al., 2014 · Open in CIViC	civic
〃	Pleomorphic Xanthoastrocytoma	Predictive	C	Supports Sensitivity Response	—	submitted	EID3786 An anaplastic pleomorphic xanthoastrocytoma patient harboring BRAF V600E mutation was associated with improved response to vemurafenib treatment. The patient was treated with radiation and temozolomid… (full text at CIViC) PMID 25092772 · Lee et al., 2016 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	3	accepted	EID6045 In a phase 2 “basket” study of vemurafenib in BRAF V600-positive non-melanoma cancers, seven patients with anaplastic thyroid cancer were enrolled. All 7 patients had V600E mutations. One complete res… (full text at CIViC) PMID 26287849 · Hyman et al., 2015 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	submitted	EID3744 In an 80 year old female anaplastic thyroid cancer patient harboring BRAF V600E and TP53 E180K co-mutations, BRAF V600E was associated with response to vemurafenib treatment. Prior to identification o… (full text at CIViC) PMID 27532222 · Prager et al., 2016 · Open in CIViC	civic
Pertuzumab + VemurafenibCombination	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID5961 The phase 2a MyPathway study assigned patients with HER2, EGFR, BRAF or SHH alterations to treatment with pertuzumab plus trastuzumab, erlotinib, vemurafenib, or vismodegib, respectively. One patient … (full text at CIViC) PMID 29320312 · Hainsworth et al., 2018 · Open in CIViC	civic