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US FDA has safety and efficacy concerns in accelerated approval of Kyprolis for multiple myeloma

This article was originally published in Scrip

Executive Summary

Onyx Pharmaceuticals' hopes for a quick market launch of its second generation proteasome inhibitor Kyprolis (carfilzomib) were dimmed on 18 June, when the US FDA released its highly sceptical analysis of the company's request for accelerated approval of the drug for patients with relapsed and refractory multiple myeloma. The FDA concluded that "the risks of carfilzomib may not outweigh its benefits".

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