- FDA Announcements
FDA Approved for RRMM: Kyprolis (carfilzomib) + Revlimid (lenalidomide) and Dexamethasone (KRd)
Updated: Oct 16, 2021
July 24, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.
The FDA approved the expanded indication for Kyprolis based on data from the ASPIRE study. The study showed that patients treated in the KRd arm lived 50 percent longer (8.7 months) without their disease worsening compared to patients treated with Revlimid and low-dose dexamethasone (Rd) alone. The median progression-free survival (PFS) was 26.3 months (95 percent CI, 23.3 to 30.5 months) in the KRd arm compared to 17.6 months (95 percent CI, 15.0 to 20.6 months) in the Rd arm. The most common all grade treatment related adverse events in the ASPIRE trial included neutropenia (34.2 percent), anemia (25.5 percent), fatigue (22.4 percent) and thrombocytopenia (22.4 percent).
07/24/2015 - Efficacy-Accelerated Approval