Kyprolis carfilzomib regulatory update

FDA accepted and granted Priority Review to an sNDA from Amgen for Kyprolis carfilzomib to treat relapsed multiple myeloma (MM) in patients who have received >=1 prior therapy. The PDUFA date is July 26. In 2012, FDA granted accelerated approval to the selective proteasome inhibitor to treat MM in patients who have received >=2 prior lines of therapy that include Velcade bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Amgen said the sNDA also supports conversion of the accelerated approval to full approval. ...