With the FDA granting priority review status, a response should be out by Jul 26. We note that the FDA grants priority review status to candidates that have the potential to bring significant improvements in terms of safety or effectiveness in the treatment, diagnosis or prevention of serious diseases when compared to currently available therapies.
We remind investors that Kyprolis is under review in the EU as well for the same indication.
We note that Kyprolis had gained accelerated approval in the U.S. in 2012 for the treatment of patients with multiple myeloma who have received at least two prior therapies including Velcade and an immunomodulatory agent (IMiD) and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Kyprolis became part of Amgen’s portfolio following its acquisition of Onyx and registered sales of $331 million in 2014. Kyprolis’ label expansion would expand the patient population and increase its commercial potential significantly.
Meanwhile, earlier this month, Amgen reported that Kyprolis performed better than Velcade in a phase III study (ENDEAVOR). The company intends to present full data at the annual meeting of the American Society of Clinical Oncology.