Amgen Advances Cancer Drug KyprolisBy
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Amgen’s Kyprolis (carfilzomib) for injection in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone (KRd) for treating patients with multiple myeloma who have received one to three prior lines of therapy. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.
Kyprolis is a product of Onyx Pharmaceuticals, Inc, a subsidiary of Amgen, and which Amgen acquired in 2013. Amgen holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel, Mexico, and Thailand.
Kyprolis is a proteasome inhibitor that was first approved by the FDA in 2012 to treat multiple myeloma.
Also, Amgen has submitted an sNDA to the FDA for expanded indication for Kyprolis for relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the United States for the treatment of patients with relapsed multiple myeloma as a monotherapy.
Source: Amgen (Combo Therapy) and Amgen (sNDA submission)