Data shows Kyprolis should be 'standard of care', claims Amgen

The US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) based on data demonstrating that Kyprolis (carfilzomib) and dexamethasone reduced the risk of death and increased overall survival versus Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory multiple myeloma.

These data showed a 21% reduction in risk of death and an overall survival benefit of 7.6 months in the Kyprolis and dexamethasone arm of the head-to-head Phase III ENDEAVOR trial.

Kyprolis is an approved multiple myeloma treatment from US biotech Amgen (Nasdaq: AMGN), as is Velcade, an older drug owned by a subsidiary of Japan’s Takeda Pharmaceutical (TYO: 4502).