Posted by Michael Wonder on 07 Aug 2018
Array Biopharma receives FDA breakthrough therapy designation for Braftovi in combination with Mektovi and cetuximab for BRAF V600E mutant metastatic colorectal cancer
7 August 2018 - Designation based on Phase 3 BEACON CRC safety lead-in data.
Array BioPharma today announced it has received breakthrough therapy designation from the U.S. FDA for encorafenib (Braftovi), in combination with binimetinib (Mektovi) and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) as detected by an FDA-approved test, after failure of one to two prior lines of therapy for metastatic disease.
BRAFV600E-mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation, and currently there are no therapies specifically approved for this high unmet need population.
