Amgen and its subsidiary, Onyx Pharmaceuticals Inc., have announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Kyprolis (carfilzomib), seeking its approval as a treatment for relapsed myeloma patients who have received at least one prior treatment. In addition, a supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration (FDA), designed to support the conversion of accelerated approval to full approval and expand the current approval indication. Both applications are based on data from the International Phase III ASPIRE trial (Kyprolis, Revlimid® and dexamethasone versus Revlimid and dexamethasone) in relapsed myeloma together with other relevant data.

 

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