The FDA has granted priority review status to Amgen's supplemental New Drug Application for its carfilzomib (Kyprolis) cancer therapy.
The FDA has granted priority review status to Amgen’s supplemental New Drug Application (sNDA) for its carfilzomib (Kyprolis) cancer therapy.
Kyprolis is currently approved to treat multiple myeloma patients who have tried and failed at least 2 prior therapies, including bortezomib and an immunomodulatory agent. The sNDA seeks to expand the cancer therapy’s use for patients with relapsed multiple myeloma who have received at least 1 prior therapy.
The submission is based on data from the phase 3 ASPIRE trial, which examined Kyprolis in combination with lenalidomide and low-dose dexamethasone, compared with lenalidomide and low-dose dexamethasone alone.
"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 Harper, executive vice president of Research and Development at Amgen, in a press release. "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 FDA is expected to act on the sNDA on July 26, 2015.