FDA NewsVideo

VIDEO: BRAF-MEK combination represents ‘important new therapy’ for melanoma

Victor Sandor, MD, chief medical officer of Array Biopharma, spoke with HemOnc Today about the FDA’s approval of a two-drug combination for a subset of patients with melanoma.

The agency today approved use of the BRAF inhibitor encorafenib (LGX818, Array BioPharma) and the MEK inhibitor binimetinib (MEK162, Array BioPharma) for treatment of BRAF-mutant advanced, unresectable or metastatic melanoma.

“We believe this represents an important new therapy for patients with BRAF-mutant melanoma,” Sandor told HemOnc Today.

The FDA based the approval on results of the phase 3 COLUMBUS trial. Results presented at ASCO Annual Meeting showed combination therapy with encorafenib and binimetinib significantly improved OS compared with vemurafenib (Zelboraf, Genentech) monotherapy or encorafenib monotherapy.

Read more about the FDA approval on Healio.com/HemOnc.

Victor Sandor, MD, chief medical officer of Array Biopharma, spoke with HemOnc Today about the FDA’s approval of a two-drug combination for a subset of patients with melanoma.

The agency today approved use of the BRAF inhibitor encorafenib (LGX818, Array BioPharma) and the MEK inhibitor binimetinib (MEK162, Array BioPharma) for treatment of BRAF-mutant advanced, unresectable or metastatic melanoma.

“We believe this represents an important new therapy for patients with BRAF-mutant melanoma,” Sandor told HemOnc Today.

The FDA based the approval on results of the phase 3 COLUMBUS trial. Results presented at ASCO Annual Meeting showed combination therapy with encorafenib and binimetinib significantly improved OS compared with vemurafenib (Zelboraf, Genentech) monotherapy or encorafenib monotherapy.

Read more about the FDA approval on Healio.com/HemOnc.