Array BioPharma Submits NDAs For Binimetinib & Encorafenib In Advanced Melanoma

(RTTNews) - Array BioPharma Inc. (ARRY), a biopharmaceutical company focused on targeted small molecule drugs to treat cancer patients, announced Wednesday the submission of two New Drug Applications or NDAs to the U.S. Food and Drug Administration.

The NDAs are submitted to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

The submissions are supported by data from the pivotal Phase 3 COLUMBUS study, which showed that patients who received binimetinib and encorafenib had a significantly longer progression free survival or PFS compared to patients receiving vemurafenib.

The COLUMBUS trial, (NCT01909453), is 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.

Ron Squarer, Chief Executive Officer, Array BioPharma, said, "The totality of the COLUMBUS results, including estimated progression free survival, objective response rate, dose intensity and tolerability of the combination, provide a strong and consistent theme across multiple endpoints for this study. We look forward to working with the FDA as they review the NDA and, if approved, hope the combination of binimetinib and encorafenib will become a new option for patients with BRAF-mutant advanced melanoma."