EC OKs Variation for Marketing Authorization for Amgen’s Multiple Myeloma Drug
The European Commission (EC) has approved a variation to the marketing authorization for Amgen’s Kyprolis (carfilzomib) to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy. The extended indication marks the second approval for Kyprolis by the EC in less than a year.
Kyprolis was first approved by the EC in November 2015 for use in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The recent EC follows the US Food and Drug Administration’s approval of a supplemental new drug application in January 2016. In the US, Kyprolis is approved for the following: (1) 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 and (2) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland, Russia, Brazil, and the European Union. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.