Amgen has announced that the US Food and Drug Administration (FDA) has granted priority review for the extended use of Kyprolis (carfilzomib) as a treatment for myeloma patients. The company is looking to expand the current indication of Kyprolis in combination with Revlimid® (lenalidomide) and dexamethasone for relapsed myeloma patients who have received one to three previous lines of treatment to include it as a treatment in combination with dexamethasone for patients who have received at least one previous line of treatment. The application is based on data from the Phase III ENDEAVOUR trial which showed that Kyprolis and dexamethasone resulted in a median progression-free survival of 18.7 months compared to 9.4 months with Velcade® (bortezomib) and dexamethasone. A decision is expected in early 2016.

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