FDA clears Onyx NDA for carfilzomib in myeloma treatment

The company said, the Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the NDA is 27 July 2012.

The submission is backed by 003-A1 study, an open-label, single-arm Phase 2b trial that evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma, who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.

The primary endpoint was overall response rate, while secondary endpoints included duration of response, clinical benefit rate, overall survival, time-to-progression, progression-free survival, and safety.

The NDA submission also contained the safety data from additional carfilzomib studies.