Amgen announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a label variation for Kyprolis (carfilzomib) to include the final overall survival (OS) data from the Phase 3 ASPIRE trial. The ASPIRE trial demonstrated that the addition of Kyprolis to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent versus lenalidomide and dexamethasone alone (Rd) and extended OS by 7.9 months in patients with relapsed or refractory multiple myeloma (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 – 0.95; 1-sided p=0.0045).
"This latest positive CHMP opinion marks the second time Amgen will add overall survival data from a Phase 3 study to the label, further validating the fundamental role of Kyprolis in treating patients with relapsed or refractory multiple myeloma," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "This is a major step towards advancing Kyprolis-based regimens as standard of care, and we look forward to the European Commission's decision later this year."
Kyprolis is approved in the European Union (EU) for use in combination with lenalidomide and dexamethasone or with dexamethasone alone (Kd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The Kd regimen of twice-weekly KYPROLIS administered at 56 mg/m2 and the KRd regimen of twice-weekly Kyprolis administered at 27 mg/m2 are the first and only therapeutic combinations to demonstrate consistently improved OS versus recent standards of care in two Phase 3 trials in relapsed or refractory multiple myeloma patients (Kd versus bortezomib and dexamethasone [Vd] and KRd versus Rd).
Since its approval in 2012, approximately 80,000 patients worldwide have received Kyprolis. The Kyprolis clinical program continues to focus on providing treatment options for physicians and patients for this frequently relapsing and difficult-to-treat cancer.