Carfilzomib undergoes FDA review for new drug application

The development of carfilzomib as a potential new treatment for myeloma has reached an important milestone with the announcement that the US Food and Drug Administration (FDA) will be reviewing a New Drug Application (NDA) for carfilzomib.

Carfilzomib, a new proteasome inhibitor which works in a similar way to Velcade®, has over the last few years been extensively tested on its own and in combination with other anti-myeloma treatments, as a treatment for relapsed and/or refractory myeloma. Carfilzomib is thought to be more effective than Velcade but is associated with less severe side-effects such as peripheral neuropathy.

Onyx Pharmaceuticals, the American company developing carfilzomib, recently submitted evidence of the effectiveness of carfilzomib in relapsed and/or refractory myeloma based on results of their Phase 2b study (the 003-A1 study), as part of a NDA.

If successful, carfilzomib will be licensed and marketed as a new treatment for myeloma in the USA. A decision is expected by July 2012 and this should help pave the way for its approval and availability in Europe later in the year.

Eric Low, Chief Executive of Myeloma UK said, “Carfilzomib is an exciting new development in the treatment of myeloma and FDA approval would be an important indication that it will soon be assessed and made available by the counterpart licensing agency in Europe, the European Medicines Agency. In the meantime, Myeloma UK will be doing all we can to ensure that carfilzomib is made available to myeloma patients in the UK in an appropriate and timely way.”