Onyx Pharmaceuticals announced that the FDA has granted accelerated approval of Kyprolis (carfilzomib) for Injection, indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including Velcade (bortezomib injection; Millenium) and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. The indication for Kyprolis is based on response rate.
The approval was based on the results of the Phase 2b 003-A1 study (n=526), a single-arm, multicenter clinical trial that enrolled 266 patients with multiple myeloma who had received a median of five prior anti-myeloma regimens. The primary efficacy endpoint was overall response (ORR) and determined by an Independent Review Committee using the International Myeloma Working Group (IMWG) criteria. ORR was 22.9% and median response duration was 7.8 months.
Enrollment has been completed for the Phase 3 confirmatory clinical trial (ASPIRE trial), to evaluate the combination of lenalidomide and low-dose dexamethasone with or without Kyprolis in patients with relapsed multiple myeloma who have received one to three prior therapies. The company has an agreement with the FDA on a Special Protocol Assessment (SPA) for this trial.
Kyprolis, a proteasome inhibitor, irreversibly binds to the N-terminal threonine-containing active sites of the 20S proteasome and has antiproliferative and proapoptotic activities in solid and hematologic tumor cells.
For more information call (855) 669-9360 or visit www.onyx.com.