Wednesday July 5, 2017 0 comments
BOULDER -- 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.
Array said the submissions are supported by data from the pivotal Phase 3 COLUMBUS study, which showed 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, Array BioPharma CEO.
"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."
Array said metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. Only about 20% of people will survive for at least five years following a diagnosis with late-stage disease.
There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma.
Binimetinib and encorafenib are investigational medicines and are not currently approved in any country.
Array BioPharma said it retains exclusive rights to binimetinib and encorafenib in key markets including the U.S., Canada and Israel.
Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America.