The European Commission has approved Kyprolis to treat relapsed multiple myeloma. | Courtesy of Shutterstock
+ Regulatory
Amanda Rupp | Jul 6, 2016

EC approves Kyprolis to treat relapsed multiple myeloma

Leaders with the European Commission (EC) recently approved an extended indication for Kyprolis (Carfilzomib), which Amgen has designed to treat patients who have relapsed multiple myeloma.

This approval is based on a head-to-head Endeavor phase-three trial that showed Kyprolis and dexamethasone are more effective than Velcade and dexamethasone for patients who have relapsed multiple myeloma. Thanks to the approved indication, Kyprolis can be combined with dexamethasone to treat patients.

The most frequently seen side effects happened in more than 20 percent of the patients. They include fatigue, anemia, thrombocytopenia, diarrhea, pyrexia, respiratory tract infection, nausea, dyspnea, peripheral edema and coughing.

"In the phase-three 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," Dr. Sean Harper, executive vice president of research and development at Amgen, said. "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."

Qualifying patients must be adults who have already tried at least one other therapy without success.

This approval and extended indication serve as the second approval Kyprolis has gained from the EC in under a year.

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