Kyprolis Labeling Updated With Overall Survival Data From Multiple Myeloma Trial
Amgen announced that the Food and Drug Administration (FDA) has approved the addition of new overall survival data (OS) from the ASPIRE trial to the labeling of Kyprolis (carfilzomib). The full OS findings have been published in the Journal of Clinical Oncology.
ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) was a Phase 3 trial that evaluated the triplet regimen Kyprolis, lenalidomide, and dexamethasone (KRd) vs lenalidomide and dexamethasone (Rd) alone, in patients with relapsed or refractory multiple myeloma who received 1–3 prior regimens.
The primary endpoint was progression-free survival; secondary endpoints included OS, overall response rate, duration of response, disease control rate, health-related quality of life, and safety.
The data showed treatment with KRd not only significantly decreased mortality risk by 21% but also increased OS by 7.9 months compared with patients who received Rd alone (median OS of 48.3 months vs 40.4 months; hazard ratio [HR] 0.79; 95% CI, 0.67–0.95; P =.0091).
Kyprolis, a proteasome inhibitor, is currently indicated in combination with dexamethasone or lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1–3 lines of therapy; and as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥1 lines of therapy. It is available as 30mg and 60mg single-use vials for intravenous (IV) injection.
For more information call (800) 772-6436 or visit Kyprolis.com.