FDA Breakthrough status for Braftovi combo in colorectal cancer

The US Food and Drug Administration has granted Breakthrough Therapy designation for Braftovi (encorafenib), in combination with Mektovi (binimetinib) and cetuximab, intended to expedite development and review of drugs for serious conditions, where preliminary clinical evidence indicates that they may demonstrate substantial improvement over existing therapies.

The designation, granted to US biotech firm Array BioPharma (Nasdaq: ARRY), is 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. [1-6]

Array was up 8.7% in electronic trading, after closing Monday's session at $15.07, and the stock gained 2.9% to $15.51 this morning. The stock is in the process of bouncing from support at its 200-day moving average, which previously contained its May lows around the $13 level, noted Elizabeth Harrow of Schaeffer’s Investment Research.