2 July 2018 - - Boulder, Colorado-based cancer treatment developer Array BioPharma (NASDAQ: ARRY) has received US FDA approval of Braftovi capsules in combination with Mektovi tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test, the company said.
The approval of Braftovi + Mektovi is based on results from the phase 3 COLUMBUS trial, which demonstrated that the combination doubled median progression-free survival compared to vemurafenib alone. Only 5% of patients who received Braftovi + Mektovi discontinued treatment due to adverse reactions.
Braftovi is an oral small molecule BRAF kinase inhibitor and Mektovi is an oral small molecule MEK inhibitor which target key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK).
Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma, colorectal cancer, non-small cell lung cancer, thyroid, and others.
Array BioPharma is focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer.