Amgen announced on June 11 that the FDA had approved its supplementary application and was approved to write positive survival data in the ASPIRE Phase III study into the drug label of Kyprolis, namely: Kyprolis plus lenalidomide plus dexamethasone. Treatment of patients with relapsed and refractory multiple myeloma who had previously received 1 to 3 treatments reduced mortality risk by 21% compared to lenalidomide plus dexamethasone, extending overall survival by 7.9 months (48.3 vs 40.4 month).
The detailed results of the ASPIRE study were published earlier this year in the Journal of Clinical Oncology. In terms of safety, Kyprolis and Kyprolis have similar known adverse events. The most common adverse reactions (≥20%) include diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infections, fever, cough, hypokalemia. Hyperlipemia, thrombocytopenia, muscle cramps, pneumonia, nasopharyngitis, nausea, constipation, insomnia, bronchitis, etc.
Kyprolis was first approved by the FDA in July 2012 and has now provided treatment to 80,000 patients worldwide with multiple myeloma.