Amgen receives CHMP backing for Kyprolis label update

Amgen has announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a new label update for Kyprolis.

The European Medicines Agency committee has adopted a positive opinion recommending a label variation for Kyprolis to include updated overall survival data from a phase III head-to-head trial, ENDEAVOR. 

This study compared the performance of Kyprolis plus dexamethasone with a combination of dexamethasone and an established alternative treatment among patients with relapsed or refractory multiple myeloma.

It was demonstrated that the Kyprolis-based regimen reduced the risk of death by 21 percent and increased overall survival by 7.6 months versus the comparator, suggesting it can play a key role in helping patients experience longer and healthier lives.

Dr David Reese, senior vice-president of translational sciences and oncology at Amgen, said: "We're proud to share these results with European regulatory authorities and believe Kyprolis is advancing the standard of care for patients with relapsed or refractory multiple myeloma."

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