EU OKs Extended Indication for Amgen’s Myeloma Drug Kyprolis

Global biotech firm Amgen has announced that the European Commission (EC) approved a variation to the marketing authorization for Kyprolis (carfilzomib) to be used in combination with dexamethasone alone for adults suffering from multiple myeloma who have been treated at least once. This extended indication is the second EC approval for Kyprolis in less than a year.

Kyprolis inhibits proteasomes, organelles that play a key role in cell function by breaking down proteins that are damaged or that are no longer needed by our bodies. Kyprolis works by blocking proteasomes which can lead to an excessive buildup of proteins within cells. In some cells, Kyprolis might lead to cell death, especially in certain cancer cells that have a higher probability of containing a higher amount of abnormal proteins.

Dexamethasone is a corticosteroid similar to a natural hormone produced by our adrenal glands. It is often used to replace this hormone when our bodies don’t make enough of it.

The EC approved the extended indication for Kyprolis is based on data from the Phase 3 head-to-head Endeavor trial, in which multiple myeloma patients treated with the combination Kyprolis plus dexamethasone achieved superior progression-free survival rates when compared to those patients receiving bortezomib plus dexamethasone (18.7 months versus 9.4 months).

The primary objective of this randomized, open-label Phase 3 trial was to compare progression-free survival in multiple myeloma patients who relapsed after one to three previous therapies treated with carfilzomib plus dexamethasone or bortezomib – also a proteasome inhibitor indicated for the treatment of multiple myeloma – plus dexamethasone combinations.

The evaluated combination treatment also demonstrated superior results against bortezomib plus dexamethasone in the trial’s secondary endpoints, according to the findings presented during the 21^st Congress of the European Hematology Association (EHA).

“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,” Sean Harper, the executive vice president of research and development at Amgen, said in a press release.