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-dpdRegulatory15 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 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
EU EMA	—	MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Colorectal cancer (CRC)Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC)  with a BRAF V600E mutation, who have received prior systemic therapy. Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.  Non-small cell lung cancer (NSCLC)Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.	approved	Sep 19, 2018	ema
US FDA	—	Efficacy supplement 2026-02-24 (see label)	approved

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 2 days 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 21 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 V6005

Cetuximab + EncorafenibCombination

Malignant Colorectal NeoplasmCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

BRAF V600E6

Binimetinib + Cetuximab + EncorafenibCombination

Malignant Colorectal NeoplasmCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

KRAS Amplification1
Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	submitted	EID2928 Paired pre-treatment and post-progression tumor biopsies from BRAF-mutant CRC patients treated with RAF inhibitor combinations were analyzed. Alterations in MAPK pathway genes were found in resistant … (full text at CIViC) PMID 25673644 · Ahronian et al., 2015 · Open in CIViC	civic

KRAS Amplification1

Cetuximab + EncorafenibCombination

Malignant Colorectal NeoplasmCURATED_BROADER

Predictive

Supports Resistance

submitted

EID2928

Paired pre-treatment and post-progression tumor biopsies from BRAF-mutant CRC patients treated with RAF inhibitor combinations were analyzed. Alterations in MAPK pathway genes were found in resistant … (full text at CIViC)

PMID 25673644 · Ahronian et al., 2015 · Open in CIViC

civic