Pfizer Announces FDA Approval of BRAFTOVI® (encorafenib) in Combination with MEKTOVI® (binimetinib) for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer

On October 12, Pfizer announced that the FDA approved the supplemental New Drug Application (sNDA) for encorafenib (Braftovi) in combination with binimetinib (Mektovi) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring the BRAF V600E mutation.

Braftovi is an oral small-molecule BRAF kinase inhibitor that Array BioPharma (now acquired by Pfizer) purchased from Novartis, and Mektovi is an oral small-molecule MEK kinase inhibitor developed by Array BioPharma. In June 2018, the combination of Braftovi and Mektovi received its first FDA approval for the treatment of patients with unresectable or metastatic melanoma carrying the BRAF V600E or V600K mutation.

Currently, Pfizer holds all rights to these two products in the United States, Canada, all countries in Latin America, Africa, and the Middle East (excluding Israel). Ono Pharmaceutical has the development and commercialization rights in Japan and South Korea, while Pierre Fabre possesses the development and commercialization rights in Europe and the Asia-Pacific region (excluding Japan and South Korea).

This approval is mainly based on the positive results of the Phase II PHAROS study. This study is a multi-center, open-label, single-arm clinical trial, enrolling a total of 98 patients with metastatic NSCLC carrying the BRAF V600E mutation. The primary endpoint was the objective response rate (ORR) assessed by an Independent Radiology Review (IRR) committee. For treatment-naïve patients (n=59), the ORR was 75%; for previously treated patients (n=39), the ORR was 46%.

Currently, only the combination therapy of dabrafenib + trametinib developed by GSK and Novartis has been approved for the treatment of BRAF V600E mutation-positive NSCLC.

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