Array BioPharma Gets FDA Breakthrough Therapy Designation For BRAFTOVI

(RTTNews) - Array BioPharma Inc. (ARRY) said it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for encorafenib or 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.

As presented at the ESMO 20th World Congress on Gastrointestinal Cancer in June 2018, the results from the safety lead-in of the ongoing randomized Phase 3 BEACON CRC trial showed that, at the time of analysis, the overall survival (OS) data were fully mature through 12.6 months and that the median OS had not yet been reached.