Amgen and Onyx submit Kyprolis sNDA and marketing authorization application in USA and EU

USA-based Amgen (Nasdaq: AMGN), the world’s leading independent biotech firm, and its subsidiary Onyx Pharmaceuticals have submitted a supplemental New Drug Application to the US Food and Drug Administration for Kyprolis (carfilzomib).

The companies have also submitted a marketing authorization application to the European Medicines Agency. The applications seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. They are based on the results from the Phase III ASPIRE trial and other relevant data.

Pablo Cagnoni, president of Onyx Pharmaceuticals, said: "Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing. The US and EU submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma."