The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of accelerated approval to full approval and expand the current carfilzomib indication. As part of the acceptance, the FDA granted carfilzomib priority review with a Prescription Drug User Fee Act target action date of July 26, 2015.
Carfilzomib is currently approved by the FDA for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib (Velcade) and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The sNDA is based on data from the international randomized phase III ASPIRE trial, which evaluated carfilzomib in combination with lenalidomide (Revlimid) and low-dose dexamethasone vs lenalidomide and low-dose dexamethasone alone, in 792 patients with relapsed multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial was progression-free survival. Secondary endpoints included overall survival, overall response rate, duration of response, disease control rate, health-related quality of life, and safety.
The ASPIRE data were presented at the 56th Annual Meeting of the American Society of Hematology in December 2014 and published in The New England Journal of Medicine. ■