Amgen’s Kyprolis gets accelerated FDA review for expanded labelling
pharmafile | September 21, 2015 | News story | Sales and Marketing | Amgen, FDA, Kyprolis, carfilzomib, multiple myeloma
The FDA has accepted for priority review Amgen’s supplemental new drug application for Kyprolis (carfilzomib) for patients with relapsed multiple myeloma.
The sNDA is designed to expand Amgen’s current indication to include Kyprolis in combination with dexamethasone for patients who have received at least one prior therapy.
The FDA’s acceptance of this new sNDA for Kyprolis follows the Agency’s recent approval of 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,” says Sean Harper, 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 III head-to-head Endeavor study, which showed that patients with relapsed multiple myeloma treated with Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening.
Results demonstrated statistically and clinically-significant superiority over (Velcade) bortezomib and low-dose dexamethasone, with a median progression-free survival of 18.7 months for Kyprolis and dexamethasone versus 9.4 months for Velcade plus dexamethasone.
Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. The FDA says it expects to make a decision by January 22, 2016.
Joel Levy
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