Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI in Combination Drugs for Colorectal Cancer


Array BioPharma recently made the announcement that is has received the Breakthrough Therapy Designation from the United States FDA (Food & Drug Administration) for the drug encorafenib BRAFTOVI in combination with the drugs namely binimetinib (MEKTOVI) & cetuximab for the treatment of the patients having BRAF V600E mutation metastatic colorectal cancer (mCRC). The patients who have BRAF V600E-mutant mCRC tend to have a higher mortality rate (usually double) in the case of the patients having mCRC without the mutation. In the current scenario, there are no specific therapies that are approved for meeting the treatment requirements of such patients.

The Breakthrough Therapy Designation is an FDA-approved process of expediting the development & review of the drugs that are aimed at treating a serious health condition. In this designation process, the preliminary clinical evidence suggests that they might be able to demonstrate significant improvement over the existing therapies on over a single clinically crucial endpoint.

BRAFTOVI, also referred to as “encorafenib,” is a small oral molecule “BRAF” kinase inhibitor. At the same time, MEKTOVI, also known as “binimetinib,” is yet another small oral molecule MEK inhibitor. These drugs are aimed at targeting the key enzymes in the MAPK referring to the pathway RAS-RAF-MEK-ERK. In the United States, the drug combination of BRAFTOVI & MEKTOVI is given approval by the FDA for the treatment of metastatic or unresectable melanoma with BRAF V600E or V600K mutations.

Colorectal cancer, amongst all other forms of cancer, is the third most common type of cancer occurring men across the world. By giving the patients the combination of the drugs is expected to bring some hope into the treatment of colorectal cancer in the coming times.