Compliance Management / Small Molecule

FDA Gives Amgen Priority Review for Kyprolis sNDA

Apr 01, 2015

Amgen announced in a press release that the FDA has accepted 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 supports the conversion of accelerated approval to full approval and expand the current Kyprolis indication. As part of the acceptance, the FDA granted Kyprolis priority review with a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2015.

"Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The FDA's priority review designation for Kyprolis underscores the need for new treatment options for patients with relapsed multiple myeloma, and we look forward to working with regulatory authorities throughout the review process."

The sNDA is based on data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data.

Read the full release