FDA Approves Combination Therapy for Melanoma

The U.S. Food and Drug Administration approved the combination encorafenib and binimetinib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutation. 

The decision was based on results of the randomized, active-controlled, open-label, multicenter COLUMBUS trial that included 577 patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. Patients were randomized 1:1:1 to receive encorafenib 450 mg once daily plus binimetinib 45 mg twice daily, encorafenib 300 mg once daily, or vemurafenib 960 mg twice daily.  

#ICYMI The @US_FDA approved @ArrayBiopharma's encorafenib and binimetinib (BRAFTOVI and MEKTOVI) combination therapy for patients with unresectable or #metastaticmelanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test.

READ: https://t.co/KYCzOIRI5G pic.twitter.com/1OtsQfAnvK

— Rare Disease Report (@RareDR) June 28, 2018

The median progression-free survival was 14.9 months in the encorafenib plus binimetinib cohort and 7.3 months for the vemurafenib monotherapy arm (hazard ratio = 0.54; 95% CI 0.41-0.71; P<0.0001). Overall response rates were 63% and 40%, respectively. The median response duration was 16.6 months and 12.3 months, respectively. 

FDA approves combination of binimetinib and encorafenib for advanced #melanoma tied to BRAF mutation #CancerResearch https://t.co/VsOnubKJSb

— Les Yonemoto, MD MBA (@protoninfo) June 28, 2018

The most common adverse events (AEs) associated with the combination therapy include fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia. Five percent of patients in the encorafenib plus binimetinib arm discontinued therapy because of AEs, most commonly due to hemorrhage and headache. 

Source: U.S. Food and Drug Administration