Amgen’s Kyprolis accepted for European regulatory review

Amgen and its subsidiary Onyx Pharmaceuticals have announced that the multiple myeloma drug Kyprolis has been accepted for European regulatory review.

The European Medicines Agency has accepted a marketing authorisation application for Kyprolis, seeking approval of the injection-based therapy for the treatment of relapsed multiple myeloma patients who have received at least one prior therapy.

Kyprolis has been granted accelerated assessment status by the regulator based on the strong unmet need for a more effective treatment option for multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe.

The drug has already demonstrated its safety and efficacy benefits in the phase III clinical trial Aspire.

Dr Pablo Cagnoni, president of Onyx Pharmaceuticals, said: "Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing."

The company also submitted Kyprolis for regulatory approval in the US in January. The therapy holds orphan drug designation in both the US and Europe.