Carfilzomib Plus Dexamethasone Approved by EC for Multiple Myeloma

The approval was based on the results of the phase 3 ENDEAVOR study.

A variation to the marketing authorization of carfilzomib (Kyprolis)—it’s use in combination with dexamethasone—was approved today by the European Commission (EC) for adult patients with multiple myeloma who have advanced on at least 1 prior therapy.

The approval was based on phase 3 data submitted by Amgen, the developer of carfilzomib, from the ENDEAVOR trial. The head-to-head trial compared carfilzomib plus dexamethasone (Kd) against bortezomib plus dexamethasone (Vd) and found that Kd achieved 18.7 months of progression-free survival, compared with 9.4 months in those receiving Vd (HR = 0.53; 95% CI, 0.44-0.65; P<.0001), according to a press release. Kd, the press release said, also showed improvement over Vd for secondary endpoints such as the rate of complete response (12.5% for Kd vs 6.2% for Vd, P<.0001).

“In the Phase 3 head-to-head trial, Kyprolis in combination with dexamethasone doubled the time patients lived without their cancer progressing, as well as the rates of complete response compared to bortezomib and dexamethasone,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen, in a statement. “Kyprolis-based regimens have now shown superiority over two former standard-of-care treatment options for relapsed multiple myeloma patients, reinforcing Kyproli’' place as a foundational therapy in this patient population.