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Home Industry News Amgen receives CHMP backing for Kyprolis label update

Amgen receives CHMP backing for Kyprolis label update

5th February 2018

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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