Kyprolis sNDA Submitted for Relapsed Multiple Myeloma
Amgen announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Kyprolis (carfilzomib) for Injection, a proteasome inhibitor for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.
The sNDA submission is based on data from 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 approved for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and demonstrated disease progression on or within 60 days of completion of the last therapy.
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