On October 11, 2023, the U.S. Food and Drug Administration (FDA) approved a combination of Braftovi (encorafenib) and Mektovi (binimetinib) for people with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. BRAF is a less common genetic mutation, affecting 1-2% of individuals diagnosed with NSCLC, and is confirmed by biomarker testing.

This approval was based on results from the PHAROS (NCT03915951) clinical trial, where individuals with a BRAF V600E mutation in NSCLC treated with Braftovi (encorafenib) plus Mektovi (binimetinib) showed a meaningful benefit to individuals in terms of their rate of response, duration of response, and safety profile compared to the current standard of care. The announcement offers a new treatment option for individuals with BRAF V600E metastatic NSCLC.

Read the full announcement from the FDA here.