FDA Advisory Committee recommends Kyprolis(Onyx) for Multiple Myeloma

Onyx Pharmaceuticals announced that the FDA Oncologic Drugs Advisory Committee determined by a vote of 11-0 (with 1 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, the benefit-risk assessment is favorable for the use of Kyprolis (proposed brand name for carfilzomib). Onyx is developing Kyprolis for use in Multiple Myeloma across a variety of treatment lines. The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase IIb trial as well as supportive data from additional studies.