Amgen announced that FDA has approved the supplemental New Drug Application of Kyprolis (carfilzomib). This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.

Indication: Kyprolis is approved in the US for:

• In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
• As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

Adverse reactions: The most common adverse events occurring in at least 20% of patients treated with Kyprolis in combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia. The most common adverse events occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.

Citation: FDA approves new Kyprolis (carfilzomib) combination therapy for the treatment of patients with relapsed or refractory multiple myeloma. [news release]. Thousand Oaks, CA: Amgen; January 21, 2016. http://www.amgen.com/media/news-releases/2016/01/fda-approves-new-kyprolis-carfilzomib-combination-therapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma/. Accessed January 27, 2016.