Amgen files application in Europe to expand indication of Kyprolis to treat multiple myeloma
US biotech major Amgen (Nasdaq: AMGN) said it has filed a Variation to the Marketing Authorization Application the European Medicines Agency to expand the indication for Kyprolis (carfilzomib) in combination with dexamethasone to treat multiple myeloma.
Dr Sean Harper, executive vice president of research and development at Amgen, said: "Physicians need options to personalize treatment for complicated diseases like multiple myeloma. We look forward to continued discussions with health authorities with the goal of bringing new Kyprolis-based regimens to patients in Europe."
The company said the application is based on results from the Phase III study in which patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival (PFS) compared to those receiving Velcade(bortezomib) plus. The most common adverse events in the Kyprolis arm were diarrhea, anemia, fatigue, dyspnea, pyrexia and insomnia.
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