The European Commission 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 Amgen’s Kyprolis by the EC in less than a year.
“In the phase III 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 Harper, executive vice president of Research and Development at Amgen.
The EC approved the extended indication for Kyprolis based on data from the ENDEAVOR trial: patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival of 18.7 months compared to 9.4 months in those receiving bortezomib plus dexamethasone (HR=0.53; 95% CI: 0.44, 0.65; p <0.0001). Kyprolis also demonstrated improvement in secondary endpoints, including rates of complete response or better, which were double in patients treated with Kyprolis, at 12.5 vs. 6.2 percent (p <0.0001).
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 FDA’s approval of a supplemental New Drug Application based on the ENDEAVOR results in January.
