Pfizer Inc. announced that the FDA approved BRAFTOVI^® (encorafenib) + MEKTOVI^® (binimetinib) for treating adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This mutation can be detected through FDA-approved tests like FoundationOne Liquid CDx or FoundationOne CDx. The approval is based on the phase 2 PHAROS clinical trial, which showed significant efficacy in both treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLC.

Reference: U.S. FDA Approves Pfizer’s BRAFTOVI^® + MEKTOVI^® for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer. Pfizer Press Release. Published October 12, 2023. Accessed November 5, 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-braftovir-mektovir-braf-v600e