EC Approves Extended Indication for Amgen's Kyprolis

Amgen announced that the European Commission (EC) has approved a variation to the marketing authorization for Kyprolis (carfilzomib) to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy. The extended indication marks the second approval for Kyprolis by the EC in less than a year.

“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, M.D., executive vice president of Research and Development at Amgen. “Kyprolis-based regimens have now shown superiority over two former standard-of-care treatment options for relapsed multiple myeloma patients, reinforcing Kyprolis’ place as a foundational therapy in this patient population.”

The EC approved the extended indication for Kyprolis based on data from the Phase 3 head-to-head ENDEAVOR trial in which patients with multiple myeloma treated with Kyprolis plus dexamethasone (Kd) achieved superior progression-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving bortezomib plus dexamethasone (Vd) (HR=0.53; 95 percent CI: 0.44, 0.65; p <0.0001). Kd also demonstrated improvement over Vd for secondary endpoints, including rates of complete response or better, which were double in patients treated with Kd compared to those treated with Vd (12.5 percent vs. 6.2 percent, p <0.0001). The tolerability profile was similar in the two arms, however patients treated with Kd experienced a significantly lower rate of grade 2 or higher neuropathy events than those treated with Vd, a frequent dose-limiting toxicity in patients receiving bortezomib (6 percent [95 percent CI: 4, 8] vs. 32 percent [95 percent CI: 28, 36], respectively). The most common adverse reactions that occurred in greater than 20 percent of patients treated with Kyprolis were anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.

Kyprolis was first approved by the EC in November 2015 for use in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy based on results of the ASPIRE study. Today’s approval by the EC follows the U.S. Food and Drug Administration’s approval of a supplemental New Drug Application based on the ENDEAVOR results in January 2016.

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and very aggressive disease that accounts for approximately one percent of all cancers worldwide.2-4 In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year and 24,000 patient deaths are reported on an annual basis.