US regulators have issued a green light for Pierre Fabre and Array Biotech’s encorafenib/binimetinib combination therapy for advanced BRAF-mutant melanoma.

More specifically, the approval allows physicians to prescribe the combination to patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.

The decision was based on the Phase III COLUMBUS trial, in which median progression-free survival was 14.9 months and median overall survival was 33.6 months in patients taking the combination versus 7.3 and 16.9 months, respectively, for those taking vemurafenib.

The most common adverse reactions (≥25 percent) in patients receiving encorafenib and binimetinib were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia, the firms noted.

"We are delighted with this first approval for encorafenib and binimetinib combination treatment which provides a much needed new treatment option for patients with advanced BRAF-mutant melanoma, a serious and deadly type of skin cancer,” said Frédéric Duchesne, president and chief executive of the Pierre Fabre Pharmaceuticals Division.

“The dossiers are currently under review with EMA with the outcome of the submission anticipated in the coming months.”

Encorafenib is an oral small molecule BRAF kinase inhibitor and binimetinib 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 play a role many cancers including melanoma, colorectal cancer, and non-small cell lung cancer. Encorafenib and binimetinib are being studied in over 30 clinical trials across a number of cancer populations.

News of the approval comes just days after the groups unveiled data from a late-stage trial showing a significant improvement in one-year survival in colorectal cancer patients taking encorafenib, binimetinib and cetuximab versus the standard of care.