Pfizer Submits sNDA for Encorafenib Plus Binimetinib Combination Therapy for BRAF V600E-Mutant Metastatic NSCLC

On April 4, Pfizer announced that the FDA had accepted a 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. The PDUFA date is set for Q4 2023.

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, and all countries in Latin America, as well as in 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 sNDA is primarily based on the positive results of the Phase II PHAROS study. The study is a multicenter, open-label, single-arm clinical trial that enrolled 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. Pfizer stated that the study has met its primary endpoint, and detailed results will be presented at an upcoming medical conference.

Lung cancer is the second most common type of cancer and the leading cause of cancer-related deaths worldwide. The American Cancer Society estimates that approximately 238,000 new cases of lung cancer will be diagnosed in the United States in 2023. Non-small cell lung cancer (NSCLC) accounts for about 80-85% of all lung cancers, and BRAF V600E mutation-positive NSCLC represents approximately 2% of all NSCLC cases.

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.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article in a prominent position; if you need to reproduce it, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Live Broadcast

CUBE LIVE

PharmaCube Reader Survey Questionnaire

Thank you for your companionship. Looking forward to your feedback.

Scan the QR code to provide valuable suggestions