Onyx Pharmaceuticals Inc.’s NDA and clinical development program for the investigational multiple myeloma drug Kyprolis (carfilzomib) could be a textbook example of an appropriate accelerated approval plan, satisfying all of the criteria that have been laid out by FDA’s Oncologic Drugs Advisory Committee, panel members said at their June 20 meeting.
Although Onyx sought approval on the basis of one single-arm, Phase II trial, rather than a randomized study generally preferred by FDA and ODAC, this was acceptable given the lack of viable treatment options for heavily