EMA Recommends Amgen’s Cancer Drug Kyprolis for Approval

Amgen and its subsidiary Onyx Pharmaceuticals, Inc., report that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) of Kyprolis (carfilzomib) for injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA.

Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma. Kyprolis previously received orphan drug designation by the EMA in the European Union (EU). Orphan designation is granted for medicines intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of no more than five in 10,000.

Kyprolis was granted accelerated approval by the US Food and Drug Administration (FDA) in July 2012. Kyprolis is also approved for use in Argentina, Israel, and Mexico.The FDA granted accelerated approval of Kyprolis for treating patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. 

Source: Amgen

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