Onyx Pharmaceuticals recently announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) 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 carfilzomib (proposed brand name, Kyprolis).
Onyx is developing carfilzomib 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 carfilzomib New Drug Application (NDA) for accelerated approval is July 27, 2012.
The carfilzomib NDA submission is based on the 003-A1 study, an open-label, single-arm phase IIb trial as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib (Velcade) and either thalidomide (Thalomid) or lenalidomide (Revlimid).
Carfilzomib is being studied in several clinical trials either as a single-agent or in combination with other therapies, including: