FDA to Review Kyprolis for Relapsed Multiple Myeloma
Amgen announced that the Food and Drug Administration (FDA) has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.
The sNDA submission was based on data the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone vs. Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data.
Kyprolis is already indicated for the treatment of patient 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.
For more information visit Kyprolis.com.