FDA approves Braftovi + Mektovi in metastatic melanoma with a BRAFV600E or BRAFV600K mutation.- Array BioPharma + Pierre Fabre

Array BioPharma and Pierre Fabre announced that the FDA has approved Braftovi capsules in combination with Mektovi tablets (encorafenib + binimetinib) for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. Braftovi is not indicated for the treatment of patients with wild-type BRAF melanoma.

The approval of Braftovi + Mektovi is based on results from the Phase III COLUMBUS trial, which demonstrated the combination doubled median progression-free survival (mPFS) compared to vemurafenib, alone (14.9 months versus 7.3 months, respectively. Only 5% of patients who received Braftovi + Mektovi discontinued treatment due to adverse reactions. The most common adverse reactions (more than 25%) in patients receiving Braftovi + Mektovi were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia. As announced in February 2018, Braftovi + Mektovi reduced the risk of death compared to treatment with vemurafenib 960 mg daily in the planned analysis of overall survival (OS) from the COLUMBUS trial. Median OS was 33.6 months for patients treated with the combination, compared to 16.9 months for patients treated with vemurafenib as a monotherapy. These positive results add to the growing body of clinical evidence supporting the BRAF/MEK inhibitor combination therapy and Array and its partners are working to formally submit these results with global regulatory authorities.

FDA also granted approval of the THxID BRAF Kit (bioM�rieux) as a companion diagnostic for these therapeutics.