Amgen files for US and EU approval for new Kyprolis label update

Pharmaceutical Company Product News

Amgen has applied for regulatory approval in the US and EU for a planned update to the label of its multiple myeloma therapy Kyprolis.

A supplemental new drug application has been submitted to the US Food and Drug Administration for the proposed update, in addition to a new variation to its European Medicines Agency marketing application.

“Amgen has filed for regulatory approval to include additional overall survival data on the label for Kyprolis.“

If approved, this will allow the company to include overall survival data from the phase III head-to-head ENDEAVOR trial in the product information for Kyprolis, offering a better overview of its safety and efficacy.

In this study, it was shown that Kyprolis plus dexamethasone reduced the risk of death by 21 percent compared to an established alternative therapy regimen, resulting in a 7.6-month overall survival benefit that was consistent regardless of prior bortezomib therapy.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We know that Kyprolis may offer appropriate multiple myeloma patients a better chance for a longer life at first relapse compared to Velcade when added to dexamethasone."

Since its approval in 2012, Kyprolis has been prescribed to more than 50,000 patients worldwide.

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