By Fineline Cube 
France-based Pierre Fabre Laboratories announced that Braftovi (encorafenib) in combination with cetuximab has been approved by China’s National Medical Products Administration (NMPA). The approval is for adult patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who have previously received systemic therapy.
Braftovi’s Mechanism and Commercial Rights
Braftovi is an oral small-molecule kinase inhibitor targeting BRAF V600E. Pfizer holds exclusive commercialization rights in the United States, Canada, Latin America, the Middle East, and Africa. Ono Pharmaceutical has exclusive rights in Japan and South Korea, while Medison holds these rights in Israel. Pierre Fabre retains exclusive commercialization rights in Europe and other Asian regions, excluding Japan and South Korea.
Clinical Trial Basis
The approval in China is based on the pivotal Phase III BEACON CRC study and the bridging study NAUTICAL CRC conducted in China. The combination therapy of Braftovi and cetuximab demonstrated significant improvements in overall survival. Specifically, the therapy reduced the risk of death by 40% in the BEACON CRC study and by 45% in the NAUTICAL CRC study.-Fineline Info & Tech