FDA priority review for Amgen's sNDA for Kyprolis

The US Food and Drug Administration has accepted for priority review the supplemental New Drug Application (sNDA) for biotech major Amgen’s (Nasdaq: AMGN) Kyprolis (carfilzomib) for Injection for patients with relapsed multiple myeloma (MM), based on results of the Phase III head-to-head ENDEAVOR study.

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 for this new indication is January 22, 2016.

If approved, the decision would represent the second FDA approval in six months for Kyprolis in this patient population, providing clinicians with yet another important option in treating relapsed MM, a rare and complex blood disorder that has historically been one of the most difficult to treat blood disorders.

"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 Harper, executive vice president of R&D 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," Dr Harper added.