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 isArray BioPharma (now acquired by Pfizer) was acquired from Novartis.An oral small-molecule BRAF kinase inhibitor, Mektovi is an oral small-molecule MEK kinase inhibitor developed by Array BioPharma.In June 2018, Braftovi in combination with Mektovi was first approved by the FDA for the treatment of patients with unresectable or metastatic melanoma carrying the BRAF V600E or V600K mutation.Currently, Pfizer owns these two products in the United States, Canada, and Latin America.All countries, all rights in Africa and the Middle East region (excluding Israel), andOno Pharmaceutical has the development and commercialization rights in Japan and South Korea.Pierre Fabre owns itDevelopment 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 aMulticenter,Open-label, single-arm clinical trial, enrolled a total of 98 cases carryingPatients with metastatic NSCLC harboring BRAF V600E mutationThe primary endpoint of the study was the objective response rate (ORR) assessed by an independent medical imaging 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.Copyright © 2023 PHARMCUBE. All Rights Reserved.
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