Amgen has announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) based on the overall survival (OS) data from the phase 3 head-to-head ENDEAVOR trial demonstrating that Kyprolis (carfilzomib) and dexamethasone (Kd) reduced the risk of death by 21 percent and increased OS by 7.6 months versus Velcade (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79; p=0.01). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, 2018.
"Effective proteasome inhibition is an essential approach to treating multiple myeloma. Patients in the ENDEAVOR study receiving Kyprolis and dexamethasone lived 7.6 months longer than those on Velcade and dexamethasone," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These data, along with compelling overall survival results from the Phase 3 ASPIRE trial, clearly demonstrate that Kyprolis-based regimens should be considered new standards of care for appropriate patients with relapsed multiple myeloma."
If approved by the FDA, the Kyprolis US prescribing information will include this data from the ENDEAVOR trial showing that Kyprolis, administered at the 56 mg/m2 dose as a 30-minute infusion twice weekly with dexamethasone, helped relapsed or refractory multiple myeloma patients live longer than patients administered Vd. Full results from the ENDEAVOR OS analysis were recently published online in The Lancet Oncology.
Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR. The most common adverse events (greater than or equal to 20 percent) in the Kyprolis arm were anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache.
Since its approval in 2012, more than 50,000 patients worldwide have received Kyprolis. The Kyprolis clinical program continues to focus on providing solutions for physicians and patients in treating this frequently relapsing and difficult-to-treat cancer. Kyprolis is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations.