Posted by Michael Wonder on 07 Nov 2019
EMA validates Bratovi, Mektovi application for some mCRC
7 November 2019 - The EMA has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for BRAFV600E-mutant metastatic colorectal cancer.
The combination, which also includes cetuximab, has the potential to be the first chemotherapy-free, targeted regimen for patients with advanced colorectal cancer if it is approved.
The company revealed that the application was based on data from the pivotal Phase III BEACON CRC trial, which evaluated the efficacy and safety of Braftovi+Mektovi in combination with cetuximab in patients with advanced BRAFV600E-mutant metastatic colorectal cancer whose disease has progressed after one or two prior lines of therapy.
