FDA approves addition of positive overall survival data to Kyprolis label

THOUSAND OAKS, Calif. — Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the Phase 3 Aspire trial to the U.S. Prescribing Information for Kyprolis (carfilzomib).

Data added to the label showed that Kyprolis, lenalidomide and dexamethasone (KRd) significantly reduced the risk of death by 21 percent and extended overall survival by 7.9 months versus lenalidomide and dexamethasone alone (Rd) 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% CI, 0.67 – 0.95; two-sided p=0.0091).

“Amgen is focused on advancing treatment options that have the potential to transform outcomes for patients,” said Dr. David Reese, senior vice president of translational sciences and oncology at Amgen. “The Aspire trial showed significant improvement in survival in patients with relapsed or refractory multiple myeloma who received Kyprolis as part of a triplet regimen. With this approval, the U.S. Prescribing Information for Kyprolis now includes positive overall survival data from two Phase 3 trials, underscoring the important role of proteasome inhibition in the treatment of multiple myeloma.”

Full OS results from Aspire were published earlier this year in the Journal of Clinical Oncology. The safety data were consistent with the known safety profile of Kyprolis. The most common adverse events (greater than or equal to 20%) in the Kyprolis arm were diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia, thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis.

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 blood cancer.