Onyx falls as FDA says no priority review for cancer drug

US drugmaker Onyx Pharmaceuticals (Nasdaq: ONXX) saw its shares fall 7.1% to $37.76 in early trading yesterday, though closed the day just 4% lower at $39, after the company revealed that the US Food and Drug Administration has refused its application for accelerated review of its cancer drug candidate carfilzomib, which it made in the fall (The Pharma Letter September 29).

The FDA has granted Standard Review designation to the New Drug Application for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the agency is July 27, 2012. The drug, acquired with Onyx’ $851 million buy of Proteolix, is licensed to Ono Pharma for the Japanese market (TPL September 9, 2010).

In the NDA filing designation letter from the FDA, received December 9, the agency advised the company that recent Oncology Drug Advisory Committee recommendations specify a preference for Phase III trials for the accelerated approval pathway. Based on its preliminary review and ongoing assessment of the application, the FDA outlined potential review issues including whether the application is sufficient to support an FDA conclusion that the data provided within the NDA meets accelerated approval criteria and whether the benefit and risk are appropriately balanced, given that the application is based on a single-arm study.