Amgen, the US biopharmaceutical company, has announced it has submitted an application to the European Medicines Agency (EMA) to expand the indication for Kyprolis (carfilzomib) in combination with dexamethasone as a treatment for relapsed myeloma patients who have received at least one previous line of treatment. The application is based on data from the Phase III ENDEAVOR trial – a head to head study which showed that patients receiving Kyprolis and dexamethasone achieved a doubling in progression free survival compared to those receiving Velcade® and dexamethasone. Kyprolis is currently licensed for use in Europe in combination with Revlimid® and dexamethasone for relapsed and/or refractory myeloma patients. A decision on the expanded application is expected in 2016.


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