Policy & Regulation
Array BioPharma submits Binimetinib & Encorafenib NDA with the US FDA for advanced BRAF-mutant melanoma
13 September 2017 -

Biopharmaceutical company Array BioPharma (Nasdaq:ARRY) said on Tuesday that it has filed its New Drug Applications (NDAs) of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) with the US Food and Drug Administration (FDA) for review for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma, the most serious and life-threatening type of skin cancer associated with low survival rates.

The company added that the US FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of 30 June 2018 for both the applications.

According to the company, binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in this pathway.

This NDA submission was based on findings from the company's pivotal Phase 3 COLUMBUS trial, a two-part, international, randomized, open label Phase 3 study evaluating the efficacy and safety of the combination of binimetinib plus encorafenib to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutation across North America, Europe, South America, Africa, Asia and Australia.

In Part 1, 577 patients were randomised 1:1:1 to receive 45mg binimetinib plus 450mg encorafenib (COMBO450), 300mg encorafenib alone, or 960mg vemurafenib alone. In Part 2, 344 patients were randomised 3:1 to receive 45mg binimetinib plus 300mg encorafenib or 300mg encorafenib alone, disclosed the company.