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news.Amgen and its subsidiary Onyx Pharmaceuticals have submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) as well as a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for Kyprolis (carfilzomib) for Injection.
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Kyprolis is currently indicated in the US to treat patients with relapsed multiple myeloma who have received at least two other treatments.
The sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication.
In the European Union (EU), the EMA granted orphan drug designation for Kyprolis as well as granted accelerated assessment of the MAA.
Both the sNDA and MAA are based on data from the Phase III ASPIRE trial, which evaluated Kyprolis in combination with lenalidomide and low-dose dexamethasone, versus lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens.
Onyx Pharmaceuticals president Pablo Cagnoni 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."
Onyx conducted the ASPIRE trial under a Special Protocol Assessment (SPA) from the FDA and received Scientific Advice from the EMA on the design and planned analysis of the trial.
Currently, Kyprolis (carfilzomib) for Injection is approved for use in Argentina, Israel and Mexico.