The drug’s second indication in less than a year will let it be used in combination with dexamethasone alone in adults with multiple myeloma who have received at least one prior therapy.
The approval was based on data from the head-to-head Phase III Endeavor study, which demonstrated the median progression-free survival (PFS) with carfilzomib plus dexamethasone was 18.7 versus 9.4 months with bortezomib plus dexamethasone.
In addition to its success with PFS, the combination achieved a higher overall response rate of 76.9% versus 62.6% with bortezomib and dexamethasone.
Amgen research and development executive vice president Sean Harper said: "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.
"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 initially approved Kyprolis in November 2015 for use in combination with lenalidomide and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy.
Earlier this year, the US Food and Drug Administration’s approved a supplemental New Drug Application based on the Endeavor results.
Kyprolis has been demonstrated to block proteasomes, resulting in an excessive build-up of proteins within cells.
In various cells, Kyprolis can lead to cell death, particularly in myeloma cells as they are more likely to feature a higher amount of proteins that are abnormal.
Image: Kyprolis Product Image. Photo: courtesy of Amgen Inc.