Onyx Pharmaceuticals announced that the FDA has granted fast track designation to carfilzomib for the treatment of relapsed and refractory multiple myeloma. Positive complete results from the Phase 2b 003-A1 study evaluating single-agent carfilzomib in patients with relapsed and refractory multiple myeloma were recently announced at the American Society of Hematology (ASH) meeting in December 2010. Through the Fast Track designation, Onyx is eligible to submit the carfilzomib NDA on a rolling basis, allowing Onyx to begin the NDA filing process immediately and giving the FDA an opportunity to review the completed sections of the registration application.
Carfilzomib is a selective, next-generation proteasome inhibitor that is being investigated in a broad clinical trial program in multiple myeloma.
For more information call (510) 597-6500 or visit www.onyx-pharm.com.