"The expanded indication of Kyprolis provides patients with relapsed multiple myeloma a new therapeutic option, helping to address a real unmet need for this common blood cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
"The approval of a second indication for Kyprolis in just three years demonstrates that it is becoming a critical component in the treatment of multiple myeloma, and underscores our commitment to advancing care for patients with this challenging disease."
The FDA approved the expanded indication for Kyprolis based on data from the ASPIRE study. The study showed that patients treated in the KRd arm lived 50 percent longer (8.7 months) without their disease worsening compared to patients treated with Revlimid and low-dose dexamethasone (Rd) alone.
The median progression-free survival (PFS) was 26.3 months (95 percent CI, 23.3 to 30.5 months) in the KRd arm compared to 17.6 months (95 percent CI, 15.0 to 20.6 months) in the Rd arm. The most common adverse events in the Kyprolis arm included pneumonia (1 percent), myocardial infarction (0.8 percent) and upper respiratory tract infection (0.8 percent).
"The ability of this Kyprolis treatment regimen to produce deep and durable responses is critical towards extending the time patients live without their disease progressing," said ASPIRE principal investigator Keith Stewart, M.D., Ch.B.
Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.
Multiple myeloma is the second most common hematologic cancer.1 In the U.S., there are nearly 96,000 people living with, or in remission from, multiple myeloma.
The estimated number of new cases of multiple myeloma in 2014 was more than 24,000 and the estimated number of deaths was 11,090.