In 2011, the Oncologic Drugs Advisory Committee agreed with FDA that, except in rare cases, single-arm trials are not sufficient for accelerated approval. Last week, ODAC determined Kyprolis carfilzomib from Onyx Pharmaceuticals Inc. is just such a rare case.

ODAC voted 11-0 with one abstention that the benefit-risk profile for Kyprolis is favorable in relapsed multiple myeloma (MM) patients refractory to two prior therapies including a proteasome inhibitor and an immunomodulatory agent.