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Encorafenib and Binimetinib
Encorafenib and binimetinib are a combination of a BRAF inhibitor and a MEK inhibitor that block the MAPK signaling pathway in BRAF-mutant melanoma cells.
Encorafenib and binimetinib are a combination of a BRAF inhibitor and a MEK inhibitor that block the MAPK signaling pathway in BRAF-mutant melanoma cells. Used for Unresectable or metastatic melanoma with BRAF V600E or V600K mutation, BRAF-mutant colorectal cancer (in combination, pipeline indication).
At a glance
| Generic name | Encorafenib and Binimetinib |
|---|---|
| Also known as | Encorafenib: Braftovi / Binimetinib: Mektovi |
| Sponsor | Pierre Fabre Medicament |
| Drug class | BRAF inhibitor + MEK inhibitor combination |
| Target | BRAF V600E/K and MEK1/2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Encorafenib inhibits BRAF V600E/K mutations, while binimetinib inhibits MEK1/2 downstream in the same pathway. Together, they provide dual inhibition of the MAPK cascade, preventing tumor cell proliferation and survival in BRAF-mutant cancers. This combination approach reduces the emergence of resistance mutations compared to single-agent BRAF inhibition.
Approved indications
- Unresectable or metastatic melanoma with BRAF V600E or V600K mutation
- BRAF-mutant colorectal cancer (in combination, pipeline indication)
Common side effects
- Diarrhea
- Fatigue
- Nausea
- Vomiting
- Rash
- Elevated liver enzymes
- Retinal vein occlusion
Key clinical trials
- Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis (PHASE2)
- An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer (PHASE2)
- The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials (PHASE4)
- Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement (PHASE2)
- A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma (PHASE2)
- A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma (PHASE3)
- Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma (EARLY_PHASE1)
- Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Encorafenib and Binimetinib CI brief — competitive landscape report
- Encorafenib and Binimetinib updates RSS · CI watch RSS
- Pierre Fabre Medicament portfolio CI