FDA approves new indication for Amgen’s Kyprolis

SILVER SPRING, Md. — The Food and Drug Administration approved a new indication for Amgen’s combination therapy Kyprolis, which is meant to treat relapsed or refractory multiple myeloma that has been treated with one or more therapy lines. 

 

“Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs,” Amgen’s EVP research and development Dr. Sean Harper said. “Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer.”

 

This is the second new indication the FDA has given Kyprolis in six months, the company said, noting that in July 2015, it was approved to treat multiple myeloma alongside lenalidomide and dexamethasone in patients who had undergone one to three earlier therapy lines. 

 

“As a clinician, I'm pleased with the tremendous progress that we have seen in the past 12 months in multiple myeloma treatment,” said Dr. Ruben Niesvizky, director of the Multiple Myeloma Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center. “This FDA approval is important because it provides physicians with flexible options for Kyprolis use in helping to manage this challenging disease.”