Encorafenib
Encorafenib is a BRAF inhibitor that, with cetuximab and chemotherapy, became first-line standard for BRAF-mutant colorectal cancer in 2026.
With binimetinib in melanoma (COLUMBUS); with cetuximab in BRAF V600E colorectal cancer (BEACON, 2020); BREAKWATER with cetuximab and FOLFOX in first-line BRAF V600E mCRC (accelerated December 2024, full approval 2026 with OS benefit). Also in BRAF V600E NSCLC with binimetinib.
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 450 mg once daily with binimetinib (melanoma); 300 mg once daily with cetuximab ± FOLFOX (colorectal)
- Dose modifications
- Reduce for uveitis, QTc, hepatotoxicity
- Monitoring
- Dermatologic exams (new primary skin cancers), ECG, LFTs, eye exams
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Pfizer Oncology Together
- Pfizer RxPathways
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- With binimetinib for BRAF V600 mutation-positive melanoma
- Notes
- With cetuximab for BRAF V600E metastatic colorectal cancer after systemic therapy: TA668 (2020, CDF then routine).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA562 · SMC advice: encorafenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 27 Jun 2018ApprovalUS
BRAF V600 melanoma with binimetinib (COLUMBUS) source
- 8 Apr 2020ApprovalUS
BRAF V600E metastatic CRC with cetuximab after prior therapy (BEACON) source
- 11 Oct 2023ApprovalUS
BRAF V600E NSCLC with binimetinib source
- 20 Dec 2024ApprovalUS
First-line BRAF V600E mCRC with cetuximab and mFOLFOX6 (BREAKWATER, accelerated) source
- Q1 2026ApprovalUS
Full approval in first-line BRAF V600E mCRC with OS benefit source
Approvals
| 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 |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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