Amgen-Onyx File for Full Approval for Kyprolis in MM

Amgen and its subsidiary Onyx Pharmaceuticals have submitted filings for their multiple myeloma drug Kyprolis (carfilzomib) on both sides of the Atlantic. The companies are seeking approval to market their drug for the treatment of patents with relapsed multiple myeloma who have received at least one prior therapy.

In the US, Kyprolis is already cleared under accelerated approval for use in patients with multiple myeloma who have already received at least two other treatments and whose disease has progressed; a supplemental New Drug Application has now been filed to support the conversion of this to full approval and expand target population.

In the European Union, Kyprolis has received orphan drug designation and the marketing application has been granted accelerated assessment.

Complete report on PharmaTimes:

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