Amgen receives positive CHMP opinion to extend indication of Kyprolis for the treatment of relapsed multiple myeloma

Pivotal head-to-head ENDEAVOR study shows Kyprolis plus dexamethasone doubled progression-free survival compared to Velcade (Bortezomib) and dexamethasone.

"In the first ever comparative Phase III head-to-head study of two proteasome inhibitors in relapsed multiple myeloma, Kyprolis in combination with dexamethasone nearly doubled progression-free survival compared to a current standard of care regimen," said Sean E. Harper, executive vice president of Research and Development at Amgen. "We are pleased that the CHMP has recognized these robust data with a positive opinion, and we look forward to ensuring approval of this extended indication of Kyprolis."

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 (PFS) of 18.7 months compared to 9.4 months in those receiving Velcade (bortezomib) plus dexamethasone, (HR=0.53; 95% CI: 0.44,0.65 p<0.0001). The most common adverse reactions that occurred in greater than 20% of patients in the Kyprolis arm were anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.

The CHMP positive opinion will now be reviewed by the European Commission (EC) and if granted, the marketing authorization will be extended to include Kyprolis in combination with dexamethasone in the 28 member countries of the European Union, as well as Iceland, Lichtenstein and Norway. The extended indication adopted by the CHMP is: Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

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. CHMP's positive opinion follows the FDA's approval of a supplemental New Drug Application based on the ENDEAVOR results in January 2016.