EU CHMP recommends Kyprolis (carfilzomib) + dexamethason in adult patients with multiple myeloma who have received at least one prior therapy- Amgen

Amgen has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion to extend the current indication for Kyprolis (carfilzomib) to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.

The CHMP positive opinion is based on data from the Phase III head-to-head ENDEAVOR study in which patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival of 18.7 months compared to 9.4 months in those receiving Velcade (bortezomib) plus dexamethasone. The most common adverse reactions that occurred in greater than 20 percent of patients in the Kyprolis arm were anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.

Comment: The EC previously granted marketing authorization for Kyprolis in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy based on results of the ASPIRE study in November 2015. The latest CHMP positive opinion follows FDA approval of a supplemental New Drug Application based on the ENDEAVOR results in January 2016.