Additional Relevant Details
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.