Categorized | Melanoma News, Regulatory

FDA accepts application for binimetinib-encorafenib combination for BRAF-mutated melanoma

Source: Healio, September 2017

The FDA accepted for review new drug applications that seek the use of the COMBO450 regimen to treat patients with BRAF-mutant advanced, unresectable or metastatic melanoma, according to the drugs’ manufacturer.
COMBO450 is comprised of binimetinib (MEK162, Array BioPharma), an oral small molecule MEK inhibitor, and encorafenib (LGX818, Array BioPharma), a novel oral small molecule BRAF inhibitor.
The application included data from the pivotal phase 3 COLUMBUS trial, designed to make three comparisons — COMBO450 vs. monotherapy with the BRAF inhibitor vemurafenib (Zelboraf, Genentech); COMBO450 vs. encorafenib alone; and encorafenib monotherapy vs. vemurafenib monotherapy — for patients with BRAF-mutant advanced, unresectable or metastatic melanoma. Patients assigned the COMBO450 regimen received 45 mg binimetinib twice daily and 450 mg encorafenib once daily.
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