Kyprolis (carfilzomib) filed with FDA for expanded indication in multiple myeloma- Amgen

Amgen announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Kyprolis (carfilzomib) to seek an expanded indication for the treatment of patients with relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy.

The sNDA is based on data from the global Phase III ENDEAVOR trial. The ENDEAVOR study is the first of two head-to-head Phase III trials of Kyprolis versus Velcade (bortezomib). Relapsed multiple myeloma patients treated with Kyprolis and dexamethasone in the ENDEAVOR study lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade (median progression-free survival [PFS] 18.7 months versus 9.4 months). The Kyprolis combination demonstrated superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature and continue to be monitored. Treatment discontinuation due to adverse events and on-study deaths was comparable between the two arms.

Comment: Based on the Phase III ASPIRE study Amgen continues to work with the FDA on the related sNDA in the U.S. and with the European Union regulatory authorities for the Marketing Authorization Application for Kyprolis. Following potential approval based on the ASPIRE study, Amgen plans to submit ENDEAVOR data for potential authorization in the EU.