Multiple Myeloma Drug Receives Another FDA Approval

The FDA has expanded the indication for Amgen's carfilzomib (Kyprolis) in combination with lenalidomide (Revlimid) and dexamethasone to treat patients with relapsed multiple myeloma who have received at least 1 prior 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," stated Sean E. Harper, MD, executive vice president of Research and Development at Amgen.

The approval of the supplemental New Drug Application (sNDA) was based on the results of the phase 3 ASPIRE trial, which examined Kyprolis in combination with Revlimid and low-dose dexamethasone, compared with Revlimid and low-dose dexamethasone alone.

Another sNDA recently submitted to the FDA is based on data from the ENDEAVOR trial, a head-to-head phase 3 study of Kyprolis and bortezomib (Velcade).

In that trial, which enrolled relapsed multiple myeloma patients who had failed at least 1 prior therapy, those treated with Kyprolis and dexamethasone 20 mg lived twice as long and were half as likely to see their disease worsen than those who received the Velcade combination.

“Multiple myeloma has historically been one of the most difficult to treat diseases because of the inherent complexities related to the recurring pattern of remission and relapse,” stated Dr. Harper. "…Submission of this new sNDA for Kyprolis is important because if approved, it will mean more treatment options for patients with this serious disease.”

In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis arm than the Velcade arm, and there was also an increased incidence of hypertension and dyspnea in the Kyprolis group than the Velcade group.

Kyprolis is also being evaluated in transplant-ineligible patients with newly diagnosed multiple myeloma in the phase 3 CLARION trial.

The injectable drug is also indicated as a monotherapy for patients with multiple myeloma who have received at least 2 prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.