FDA Expands Use of Kyprolis in Multiple Myeloma

According to Amgen, the US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.

"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."

Approval comes on the heels of data from the ASPIRE study, which demonstrated that patients treated in the treatment arm (which included receiving all three drugs) lived 50 percent longer (8.7 months) without their disease worsening compared to patients treated with only Revlimid and low-dose dexamethasone.

Median progression-free survival (PFS) was 26.3 months in the treatment arm compared to 17.6 months in the other arm.

Source: Amgen