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Encorafenib is a BRAF inhibitor that, with cetuximab and chemotherapy, became first-line standard for BRAF-mutant colorectal cancer in 2026.
Encorafenib is an ATP-competitive BRAF V600 inhibitor with a long target residence time, giving sustained pathway suppression. It is used with binimetinib in BRAF V600 melanoma (COLUMBUS, approved 2018), with cetuximab in previously treated BRAF V600E colorectal cancer (BEACON, 2020), and with cetuximab plus FOLFOX first line for BRAF V600E metastatic colorectal cancer after BREAKWATER (accelerated approval December 2024, full approval 2026 with an overall survival benefit); it is also used with binimetinib in BRAF V600E NSCLC. In colorectal cancer the EGFR antibody is essential because BRAF blockade alone triggers feedback reactivation through EGFR. Dosing is 450 mg daily with binimetinib or 300 mg daily with cetuximab; new primary skin cancers are a class risk. For a newcomer: the BRAF drug that finally worked in bowel cancer once paired with the right partners.
ATP-competitive BRAF V600 inhibitor with long target residence time. Connects to BRAF and EGFR.
1.Oral drug is absorbed and reaches the tumour
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. BRAF V600E documented; colorectal use requires cetuximab (Part B) alongside.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA562 · SMC advice: encorafenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2019-06-17 | Array BioPharma to Pfizer (incl. Seagen) Encorafenib (Braftovi) and binimetinib (Mektovi) | Acquisition | not disclosed | $11.4bn | source |
BRAF V600 melanoma with binimetinib (COLUMBUS) source
BRAF V600E metastatic CRC with cetuximab after prior therapy (BEACON) source
BRAF V600E NSCLC with binimetinib source
In combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test
First-line BRAF V600E mCRC with cetuximab and mFOLFOX6 (BREAKWATER, accelerated) source
Full approval in first-line BRAF V600E mCRC with OS benefit source
In combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test
Confirmed: the accelerated approval of 2024 converted to traditional approval 1.2 years after it was granted. source
| Region | Year | Indication |
|---|---|---|
| US | 2018 | BRAF V600 melanoma with binimetinib |
| US | 2020 | BRAF V600E mCRC with cetuximab, previously treated |
| US | 2026 | First-line BRAF V600E mCRC with cetuximab and chemotherapy |
| US | 2024 | Metastatic colorectal cancer with a BRAF V600E mutation, with cetuximab and mFOLFOX6, previously untreated · Accelerated approval on 20 December 2024 on BREAKWATER. |
| US | 2026 | Metastatic colorectal cancer with a BRAF V600E mutation · Traditional approval granted 24 February 2026, converting the accelerated approval. |
| EU | 2018 | BRAF V600E-mutant metastatic colorectal cancer, with cetuximab · Braftovi marketing authorisation issued 19 September 2018; the EMA product page lists metastatic colorectal cancer with the BRAF V600E mutation among its uses alongside melanoma and non-small-cell lung cancer. |
| England (NICE) | 2021 | BRAF V600E mutation-positive metastatic colorectal cancer after previous systemic treatment, with cetuximab · TA668, published 6 January 2021, subject to the commercial arrangements. There is no NICE recommendation for the first-line triplet with chemotherapy. |
| Adverse event |
|---|
| Fatigue |
| Nausea |
| Diarrhoea |
| Vomiting |
| Arthralgia |
| Rash |
| Dermatologic reactions |
| New primary cutaneous malignancies |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | pfizeroncologytogether.com |
| United Kingdom | NICE: recommended with binimetinib in BRAF V600 melanoma (TA562) and with cetuximab in BRAF V600E CRC (TA668) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Patients with newly diagnosed metastatic colorectal cancer whose tumour carries a BRAF V600E mutation, which is about 8-12% of cases, should now be offered encorafenib and cetuximab together with FOLFOX from the start rather than after chemotherapy fails; median survival has roughly doubled to about two and a half years. BRAF testing at diagnosis is therefore essential, alongside RAS and mismatch repair testing. The regimen is more toxic than chemotherapy alone.
Encorafenib-binimetinib is approved for BRAF V600E lung cancer and offers a second targeted option, particularly for patients troubled by fever on dabrafenib-trametinib.
Encorafenib with cetuximab became the standard second-line treatment for BRAF V600E disease, and the platform BREAKWATER later moved into first line with chemotherapy added, doubling survival again.
Encorafenib-binimetinib is one of three standard BRAF-MEK doublets for advanced melanoma and is often chosen for its tolerability.
It stops a BRAF-mutant report being read as one uniform outlook, and it separates the class II and III mutations, which signal differently and are not covered by the encorafenib plus cetuximab label, from V600E.
It fixes the metastatic prevalence figures every subsequent trial design has used, and it separates two biomarkers that travel together: BRAF, not mismatch repair deficiency, is what makes the prognosis bad.
Query for this drug: (TITLE:"Encorafenib" OR ABSTRACT:"Encorafenib" OR TITLE:"Braftovi" OR ABSTRACT:"Braftovi") 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 Encorafenib, not a curated reading list.
Shares COLUMBUS: encorafenib plus binimetinib versus vemurafenib or encorafenib in BRAF-mutant melanoma, SWOG S1406, COLUMBUS, Melanoma (KEGG map).
Shares BRAF inhibitor + MEK inhibitor, Immunotherapy first, then BRAF/MEK (BRAF-mutant melanoma), PHAROS, BRAF V600E (and V600K).
Shares Combination Therapy for BRAF-V600E Metastatic CRCm, Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer, Ryan B. Corcoran, A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic.
Shares PHAROS, BRAF V600E (and V600K), BRAF V600E-mutant non-small-cell lung cancer, BRAF V600-mutant melanoma.
Shares Pierre Fabre, BEACON CRC, Melanoma (KEGG map), BRAF V600-mutant melanoma.
Shares Non-V600 BRAF mutations define a clinically distinct molecular subtype of metastatic colorectal cancer, Encorafenib, binimetinib, and cetuximab in BRAF V600E-mutated colorectal cancer (BEACON CRC), RAS wild-type (extended KRAS and NRAS testing), Early-onset colorectal cancer (under 50).
Shares Paolo A. Ascierto, BRAF V600-mutant melanoma, Advanced melanoma (unresectable stage III and stage IV), BRAF.
Shares Melanoma (KEGG map), BRAF V600E (and V600K), BRAF V600-mutant melanoma, Advanced melanoma (unresectable stage III and stage IV).