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Array BioPharma Submits New Drug Applications To FDA For Binimetinib And Encorafenib In Advanced Melanoma

BOULDER, Colo., July 5, 2017 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) today announced the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) 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 (PFS) compared to patients receiving vemurafenib.

"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," said Ron Squarer, Chief Executive Officer, Array BioPharma. "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."

As presented at the 2016 Society for Melanoma Research Annual Congress, results from Part 1 of the COLUMBUS study showed that COMBO450...