Onyx Pharmaceuticals has submitted the new drug application (NDA) with the US Food and Drug Administration (FDA) for carfilzomib as a treatment for the patients with relapsed and refractory multiple myeloma.
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Additionally, Onyx has requested priority review of the application, which reduces the time the FDA takes to review a new drug application.
Onyx Research and Development and Technical Operations executive vice president Ted Love said they believe the efficacy and safety data within the NDA submission provide a compelling basis for accelerated approval of carfilzomib in the relapsed and refractory treatment setting.
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