18 September 2015 - Amgen today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for injection for patients with relapsed multiple myeloma. The sNDA is designed to expand the current indication to include Kyprolis in combination with dexamethasone for patients who have received at least one prior therapy. The Prescription Drug User Fee Act (PDUFA) target action date is January 22, 2016.

The FDA's acceptance of this new sNDA for Kyprolis follows the recent FDA approval for Kyprolis in combination with Revlimid® (lenalidomide) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.

Multiple myeloma is a rare and complex blood cancer that 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. Patients face poor outcomes, which 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, M.D., 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."

For more details, go to: http://www.amgen.com/media/media_pr_detail.jsp?releaseID=2088926