FDA Grants Priority Review to Multiple Myeloma Treatment

Kyprolis is for injection in patients with relapsed multiple myeloma.

The FDA has granted priority review for the supplemental New Drug Application (sNDA) of carfilzomib (Kyprolis) for injection in patients with relapsed multiple myeloma.

The sNDA is designed to include Kyprolis in combination with dexamethasone for patients who have received at least one prior therapy. This decision follows the FDA’s approval of Kyprolis in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior therapies.

Multiple myeloma has proven to be very difficult to treat due to the recurring pattern of remission and relapse. Patients’ conditions worsen with each relapse.

“Clinicians need a range of options and robust clinical data to make informed choices that can ideally extend the time patients live without their cancer progressing,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “The acceptance of this submission is an important next step toward providing more options for patients with relapsed multiple myeloma and we look forward to working with the FDA over the coming months.”

The application is based on data from the Phase 3 ENDEAVOR study, which illustrated how patients with relapsed multiple myeloma treated with Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening. This demonstrates that the drug is statistically and clinically superior to bortezomib and low-dose dexamethasone.

Treatment discontinuation due to side effects was comparable between the 2 study arms and rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the ASPIRE study. In the ENDEAVOR study, rates of cardiac and renal failure were higher in the Kyprolis arm than the bortezomib arm. There was also an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared with bortezomib.