Onyx Pharma files NDA for multiple myeloma drug carfilzomib

California, USA-based Onyx Pharmaceuticals (Nasdaq: ONXX) says it has completed the New Drug Application submission to the Food and Drug Administration under the accelerated approval process for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma. In addition, Onyx has requested priority review of the application, which reduces the time the FDA takes to review a new drug application.

"We believe the efficacy and safety data within the NDA submission provide a compelling basis for accelerated approval of carfilzomib in the relapsed and refractory treatment setting," said Ted Love, executive vice president, R&D and technical operations at Onyx, adding:"While important strides have been made in treating patients with multiple myeloma in the last decade, this disease remains uniformly fatal, underscoring the need for new treatment options."

Will enter a market sector set to grow to $5.3 billion by 2018