BRAFTOVI encorafenib

Drug Class

BRAF kinase inhibitor

Mechanism

Encorafenib targets BRAF V600E and V600K kinases, inhibiting downstream MAPK pathway activation and reducing cancer cell growth.

Approved Indication

Treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, in combination with cetuximab, after prior therapy; treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with binimetinib.

What This Means For Patients

Braftovi (encorafenib) is a targeted kinase inhibitor used to treat metastatic colorectal cancer and advanced melanoma with BRAF V600 mutations. It blocks signaling pathways that drive cancer cell division. Approved by NMPA in June 2025, it is also accessible via the Hainan Lecheng pilot zone special-import channel.

Regulatory Approvals

• FDA — approved (2018) — label
• EMA — approved (2018) — source
• NMPA — approved (2025) — source

Pivotal Clinical Evidence

• BEACON CRC — Kopetz et al., N Engl J Med 2019 (NCT02928224) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210496s006lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/braftovi
• https://doi.org/10.1056/NEJMoa1908075