FDA grants faster review to Bayer's regorafenib
The Food and Drug Administration will conduct a faster review of Bayer HealthCare Pharmaceuticals Inc.'s cancer drug candidate regorafenib, the company said Tuesday.
The FDA will conduct a fast track review, which is intended to bring result in faster decisions about drugs for serious illnesses or unmet medical needs.
Bayer, the U.S. unit of German drugmaker Bayer AG, is developing regorafenib as a treatment for gastrointestinal stromal tumors. Those tumors mostly occur in the stomach or small intestine but that can also be found in the liver, colon, esophagus or rectum. The company has applied for FDA approval of the drug for use in patients who have not been helped by treatment with Novartis AG's drug Gleevec and Pfizer Inc.'s Sutent.
The FDA awarded orphan drug status to regorafenib, or BAY 73-4506, in February. Orphan drug status is given to drug for rare illnesses or diseases for which there is no treatment. It comes with incentives and includes marketing exclusivity if the product is approved.
Bayer said it has started a late-stage clinical trial of regorafenib. The study will include about 170 patients and will compare the drug to standard treatment. The main goal will be comparing how long patients live before they die or their disease starts to progress again. That measurement is called progression-free survival. Secondary goals will include overall survival and time to disease progression.