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Regulation
Why Onyx's single-arm trial of Kyprolis meets FDA test for accelerated approval
Singular exception
By Erin McCallister
Senior Writer
Published on
Monday, June 25, 2012
In 2011, the Oncologic Drugs Advisory Committee agreed with FDA
that, except in rare cases, single-arm trials are not sufficient for
accelerated approval. Last week, ODAC determined Kyprolis carfilzomib from Onyx
Pharmaceuticals Inc. is just such a rare case.
ODAC voted 11-0 with one
abstention that the benefit-risk profile for Kyprolis is favorable in relapsed
multiple myeloma (MM) patients refractory to two prior therapies including a
proteasome inhibitor and an immunomodulatory agent.
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