FDA Grants Priority Review to Encorafenib/Cetuximab Combo for BRAF+ mCRC

December 18, 2019 – The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of encorafenib and cetuximab as a treatment for patients with advanced BRAF V600E–mutant metastatic colorectal cancer (mCRC) following up to 2 prior lines of therapy. The designation is based on findings from the phase III BEACON CRC study, which evaluated encorafenib plus cetuximab with or without binimetinib in … (leggi tutto)