Amgen Gets Positive CHMP Opinion To Extend Indication Of Kyprolis

(RTTNews) - Amgen (AMGN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indication for Kyprolis or 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 3 head-to-head ENDEAVOR study in which patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving Velcade® (bortezomib) plus dexamethasone, (HR=0.53; 95 percent CI: 0.44,0.65 p<0.0001). 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.

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.

Today's CHMP positive opinion follows the U.S. Food and Drug Administration's approval of a supplemental New Drug Application based on the ENDEAVOR results in January 2016.