Batch of mixed opinions from FDA advisory panels

Advisory panels of the US Food and Drug Administration meeting yesterday came back with a mixture of views on approval recommendations relating to products from Onyx, Sanofi, Pfizer and Merck & Co.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 (with one abstention) that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis (the proposed brand name for carfilzomib) from USA-based Onyx Pharmaceuticals (Nasdaq: ONXX). Onyx is developing Kyprolis for use in multiple myeloma across a variety of treatment lines. The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012.

On a negative note, the FDA’s ODAC panel on voted 14-one with one abstention against a question that asked whether there was "sufficient demonstration of a positive benefit-to-risk assessment to recommend approval" of French drug major Sanofi’s (Euronext: SAN) semuloparin. The company is seeking approval of the therapy as a treatment for venous thromboembolism (VTE) among high-risk patients receiving chemotherapy for pancreatic or lung cancers or advanced or metastasizing solid tumors.