The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) for the treatment of adult patients with BRAF
V600–mutant unresectable or metastatic melanoma, according to Array BioPharma, the company developing the regimen.
The 2-year OS rates were 58% versus 43% and the 3-year OS rates were 47% versus 32% with COMBO450 versus single-agent vemurafenib, respectively. The OS benefit with the combination was maintained across all subgroups including those defined by sex, age, BRAF status, LDH level, tumor stage, and number of organs involved at baseline.
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