FDA Approves Encorafenib and Binimetinib Combo for Melanoma With BRAF Mutations

Source: Clinical Oncology News, August 2018

The FDA approved the use of encorafenib and binimetinib (Braftovi and Mektovi, Array BioPharma) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by the THxID BRAF Kit (bioMérieux), which was also approved. Encorafenib is not indicated for treatment of patients with wild-type BRAF melanoma.

The combination approval was based on the randomized, active-controlled, open-label, multicenter trial phase 3 COLUMBUS trial in 577 patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. Patients were randomized (1:1:1) to receive binimetinib 45 mg twice daily plus encorafenib 450 mg once daily; encorafenib 300 mg once daily; or vemurafenib (Zelboraf, Genentech) 960 mg twice daily.

Treatment continued until disease progression or unacceptable toxicity.