Expansion to indication of Kyprolis (carfilzomib) in multiple myeloma filed with EMA- Amgen

Amgen has announced the submission to the European Medicines Agency (EMA) of a Variation to the Marketing Authorization Application 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. In addition, Amgen has announced that The Lancet Oncology published results from the pivotal Phase III head-to-head ENDEAVOR study comparing Kyprolis (carfilzomib) plus dexamethasone to Velcade (bortezomib) plus dexamethasone in patients with relapsed multiple myeloma. The EMA application is based on these results from the ENDEAVOR study.

The data showed that patients treated with Kyprolis plus dexamethasone achieved progression-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving bortezomib plus dexamethasone, a current standard of care in relapsed multiple myeloma. These findings demonstrate that patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without disease worsening as those treated with bortezomib. The most common adverse events (greater than 25 percent) in the Kyprolis arm were diarrhea, anemia, fatigue, dyspnea, pyrexia and insomnia. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms.