FDA Approvals of 2012

26 of 39


Drug: Stivarga
Generic molecule: regorafenib
Company: Bayer HealthCare
Approval date: Sept. 27

The scoop: FDA approved regorafenib just three months after it was granted fast-track review status and more than a month ahead of the drug's PDUFA date. The drug treats metastatic colorectal cancer, and proved enticingly effective in Phase III studies. Analysts expect sales of the drug to reach $1.25 billion. Onyx Pharmaceuticals, Bayer's partner on the drug, gained $160 million upfront and a 20% royalty stream from Bayer, after filing a lawsuit with the company over ownership rights.