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FDA grants priority review to expanded use of Kyprolis for relapsed myeloma

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The FDA accepted for priority review a supplemental new drug application that seeks to expand the approved use of carfilzomib.

The supplemental application covers use of carfilzomib (Kyprolis, Amgen) in combination with dexamethasone for patients with previously treated multiple myeloma.

“Clinicians need a range of options and robust clinical data to make informed choices that can ideally extend the time patients live without their cancer progressing,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release. “The acceptance of this submission is an important next step toward providing more options for patients with relapsed multiple myeloma and we look forward to working with the FDA over the coming months.”

The FDA is expected to make a decision on the expanded indication by Jan. 22, 2016.

The supplemental application is based on results of the randomized, phase 3 ENDEAVOR trial, which compared carfilzomib plus low-dose dexamethasone vs. bortezomib (Velcade, Millennium) plus low-dose dexamethasone in 929 patients with relapsed multiple myeloma who underwent one to three prior treatment regimens. PFS served as the primary endpoint.

Results, presented at the ASCO Annual Meeting, showed patients assigned carfilzomib plus dexamethasone achieved significantly longer PFS (18.7 months vs. 9.4 months; HR = 0.53; 95% CI, 0.44-0.65) and a significantly higher overall response rate (76.9% vs. 62.6%; P < .0001). Patients assigned carfilzomib plus dexamethasone achieved a higher rate of complete response (12.5% vs. 6.2%), as well as a higher rate of very good or better partial response (54.3% vs. 28.6%).

A similar percentage of patients in the carfilzomib and bortezomib arms discontinued treatment due to adverse events (14% vs. 15.7%). Mortality related to adverse events also appeared similar in both treatment arms (3.9% vs. 3.4%).

In 2012, the FDA approved carfilzomib monotherapy for patients with myeloma who underwent at least two previous regimens that included bortezomib and an immunomodulatory agent. Earlier this summer, the FDA approved carfilzomib in combination with lenalidomide (Revlimid, Celgene) and dexamethasone for patients with myeloma who underwent one to three prior lines of therapy.