FDA Considers Another Carfilzomib Label Expansion


The FDA is considering a label expansion for Amgen's carfilzomib (Kyprolis) in relapsed multiple myeloma.

The FDA is considering a label expansion for Amgen’s carfilzomib (Kyprolis) in relapsed multiple myeloma.

The supplemental new drug application (sNDA) now under priority review proposes to expand the current indication to include the use of Kyprolis with dexamethasone in patients who have received at least 1 previous therapy.

The FDA is expected to act on this request on January 22, 2016.

"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," stated Sean 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."

Kyprolis was recently approved in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy.

The sNDA to further expand the drug’s use is based on data from the phase 3 head-to-head ENDEAVOR study, which showed that patients with relapsed multiple myeloma who were treated with carfilzomib and low-dose dexamethasone lived twice as long as those treated with bortezomib (Velcade) and low-dose dexamethasone, and without their disease worsening.

However, the rates for cardiac and renal failure were higher in the carfilzomib arm than the bortezomib arm, and there was also an increased incidence of hypertension and dyspnea in those receiving carfilzomib compared with bortezomib.

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