Drug · Small Molecule

Encorafenib

CI-DRUG-00000211Explore in graph →NCIt C98283 CHEMBL3301612 CIViC Approved

Regulatory

Approvals (15)

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-dpdRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as BRAFTOVI (DIN 02513099) under ATC L01EC03 ENCORAFENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 5, 2021	health-canada-dpd

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 15 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 3	26	10	6	65	15	CA, EU, US	Jun 27, 2018	Sep 5, 2011
Malignant Lung Neoplasm	Approved	Phase 2	2	0	0	6	1	US	Jun 27, 2018	2015-06
Malignant Colon Neoplasm	Phase3	Phase 3	3	0	1	4	0	—	—	Jun 14, 2019
Cutaneous Melanoma	Phase2	Phase 2	4	2	0	5	0	—

Curated evidence

Clinical evidence (14)

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

civicCuratedShowing 1–14 of 14 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 V600K2
Binimetinib + Encorafenib

Clinical trials

Trials with this intervention (68)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 68 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
NCT06102902	Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer	recruiting	Phase 1	30	National Cancer Institute (NCI)NIH	1	Sep 23, 2026	clinicaltrials
NCT04511013	A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

Molecule

Record

Kind: Small Molecule
Mechanism: Serine/threonine-protein kinase B-raf inhibitor
Targets: 1 gene
UNII: 8L7891MRB6
Aliases: Braftovi, BRAFTOVI, Encorafenib, LGX 818, LGX818, NVP-LGX818, NVP-LGX-818-NXA, NVP-LGX818-NXA

Data updated 18 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)	L01EC03	ENCORAFENIB
DIN (Health Canada)	02513099	BRAFTOVI
DPD drug code	100233

BRAF V6005
Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID6046 In a Phase Ib Dose-Escalation Study of Encorafenib and Cetuximab, Twenty-six patients with refractory BRAF V600 mutant metastatic CRC (mCRC) were treated with a selective RAF kinase inhibitor (encoraf… (full text at CIViC) PMID 28363909 · van Geel et al., 2017 · Open in CIViC	civic
Alpelisib + Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID6047 In a phase Ib dose-escalation study of encorafenib, cetuximab and alpelisib, twenty-eight patients with refractory BRAF V600-mutant metastatic CRC (mCRC) were treated with a selective RAF kinase inhib… (full text at CIViC) PMID 28363909 · van Geel et al., 2017 · Open in CIViC	civic
Binimetinib + EncorafenibCombination	Melanoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID7287 In a phase 3 trial, patients with melanoma with BRAF V600E or V600K mutation were randomly assigned to encorafenib plus binimetinib or vemurafenib or encorafenib. mPFS was 14·9 months (95% CI 11·0-18·… (full text at CIViC) PMID 29573941 · Dummer et al., 2018 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	4	submitted	EID13042 In the multicenter, open-label phase Ib/II trial NCT01543698, 55 patients with BRAF V600-mutant metastatic melanoma who had not previously received a BRAF inhibitor were treated with encorafenib plus … (full text at CIViC) PMID 32669376 · Sullivan et al., 2020 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID13184 In a multicenter, open-label phase Ib/II study, 55 BRAFi-naïve patients with BRAF-mutant melanoma, including 49 (89%) with BRAF V600E and 5 (9%) with BRAF V600K, received encorafenib plus binimetinib.… (full text at CIViC) PMID 32669376 · Sullivan et al., 2020 · Open in CIViC	civic

BRAF V600E6
Binimetinib + Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID7260 In a phase III trial, patients with BRAF V600E mutated metastatic colorectal cancer received triplet combination with encorafenib + binimetinib + cetuximab in a second or third-line setting. In the sa… (full text at CIViC) Open in CIViC	civic
Cetuximab + Encorafenib + NivolumabCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID12624 In a single-arm phase 1/2 trial in microsatellite stable BRAF V600E metastatic colorectal cancer (NCT04017650; n = 26), combination encorafenib + cetuximab + nivolumab achieved an ORR of 50 % among ev… (full text at CIViC) PMID 40882637 · Morris et al., 2025 · Open in CIViC	civic
Binimetinib + Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	5	accepted	EID7612 665 patients with BRAF V600E-mutated metastatic CRC were enrolled In this open-label, phase 3 trial. Patients were randomly assigned in a 1:1:1 ratio to receive encorafenib, binimetinib, and cetuximab… (full text at CIViC) PMID 31566309 · Kopetz et al., 2019 · Open in CIViC	civic
Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID9851 The open-label phase 3 BEACON CRC trial included 665 patients with BRAF V600E-mutated metastatic CRC. Patients were randomly assigned in a 1:1:1 ratio to receive encorafenib, binimetinib, and cetuxima… (full text at CIViC) PMID 31566309 · Kopetz et al., 2019 · Open in CIViC	civic
Cetuximab + Encorafenib + Fluorouracil + Leucovorin + OxaliplatinCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	submitted	EID13309 In the randomized phase 3 BREAKWATER trial, previously untreated patients with BRAF V600E-mutated metastatic colorectal cancer receiving first-line encorafenib, cetuximab, and mFOLFOX6 (n=236) had sig… (full text at CIViC) PMID 40444708 · Elez et al., 2025 · Open in CIViC	civic
Encorafenib + PanitumumabCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	submitted	EID11309 In this case series, the authors assessed the efficacy and safety of swapping cetuximab for panitumumab as some patients are unable to tolerate treatment with the mouse/human chimeric monoclonal IgG1 … (full text at CIViC) PMID 35970034 · Rausch et al., 2022 · Open in CIViC	civic