The US Food and Drug Administration (FDA) recently accepted a New Drug Application to support the combination of the MEK inhibitor, binimetinib, and the BRAF inhibitor, encorafenib, for treating patients with BRAF-mutated unresectable or metastatic melanoma.1

Encorafenib is a novel oral small molecular kinase inhibitor designed to target the mutant BRAF kinase. The BRAF kinase is a member of the RAF/MEK/ERK pathway, which has a prominent role in several key functions of melanoma, including growth, proliferation, and survival.

Results from a phase 3 trial evaluating the drug combination showed a more than doubled progression-free survival (PFS) among patients with advanced melanoma compared with vemurafenib monotherapy.2

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“The use of combination approaches to treat patients with melanoma, as well as other cancers, is no longer a just a wish for the future but is today a clinical reality with a rapidly growing evidence-base,” Paolo A. Ascierto, MD, of the Istituto Nazionale per lo Studio e la Cura dei Tumori in Naples, Italy, and colleagues, wrote in the Journal of Translational Medicine.3

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The cobimetinib plus vemurafenib combination was, for example, approved by the FDA to treat advanced melanoma with BRAFV600E or V600K mutations; dabrafenib plus trametinib was recently granted Priority Review by the FDA for patients with melanoma.4,5