US regulators will undertake a speedy review of Amgen’s Kyprolis (carfilzomib) for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

Kyprolis already has accelerated approval for use in MM patients who have been treated with two separate therapies; the current supplemental New Drug Application is designed to support conversion to full approval as well as expand the drug’s scope.

The filing is supported by data from the Phase III ASPIRE trial, which showed that patients given Kyprolis, Celgene’s Revlimid (lenalidomide) and dexamethasone had greater progression-free survival than those taking the latter two drugs alone, with the median duration of response of 28.6 months compared to 21.2 months.

The US Food and Drug Administration has granted the application a priority review, which means that Amgen can expect a decision by July 26 this year.