- FDA Announcements
FDA Approved for RRMM: Carfilzomib (PX-171-003-A1) for relapsed refractory multiple myeloma
Updated: Oct 19, 2021
SOUTH SAN FRANCISCO, Calif., July 25, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that Blood, the medical journal of the American Society of Hematology, has published results from the 003-A1 Phase 2b trial, a single-arm, multicenter clinical trial evaluating Kyprolis™ (carfilzomib) for Injection for the treatment of patients with advanced multiple myeloma, who had received a median of five prior anti-myeloma regimens. The lead author was Dr. David Siegel, Chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center.
On July 20, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
FDA Grants Accelerated Approval to Carfilzomib for Multiple Myeloma
A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma
Blood; 2012 Oct
Carfilzomib is a next-generation, selective proteasome inhibitor being evaluated for the treatment of relapsed and refractory multiple myeloma. In this open-label, single-arm phase 2 study (PX-171-003-A1), patients received single-agent carfilzomib 20 mg/m(2) intravenously twice weekly for 3 of 4 weeks in cycle 1, then 27 mg/m(2) for ≤ 12 cycles. The primary endpoint was overall response rate (≥ partial response).
Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma
07/20/2012: FDA Approval