Amgen Submits Application to EMA To Expand Indication Of Kyprolis For The Treatment Of Relapsed Multiple Myeloma

Amgen

today announced the submission to the European Medicines Agency (EMA) of a Variation to the Marketing Authorization Application (MAA) to expand the indication for Kyprolis® (carfilzomib) in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The application is based on results from the Phase 3 head-to-head ENDEAVOR 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 dexamethasone (18.7 versus 9.4 months, respectively) (p<0.0001). The most common adverse events (greater than 25 percent) in the Kyprolis arm were diarrhea, anemia, fatigue, dyspnea, pyrexia and insomnia. "Physicians need options to personalize treatment for complicated diseases like multiple myeloma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to continued discussions with health authorities with the goal of bringing new Kyprolis-based regimens to patients in Europe." The European Commission (EC) recently granted marketing authorization following accelerated assessment for Kyprolis in combination with