BioCentury
ARTICLE | Clinical News

Stivarga regorafenib regulatory update

October 1, 2012 7:00 AM UTC

FDA approved Stivarga regorafenib from Bayer to treat previously treated metastatic colorectal cancer (mCRC) a month ahead of the product's Oct. 27 PDUFA date. Onyx has co-promotion rights in the U.S. to the dual acting signal transduction (DAST) inhibitor of multiple kinases and is eligible for a 20% royalty on worldwide sales (see BioCentury, Oct. 17, 2011). Bayer said the product will be available immediately at a wholesale acquisition cost of $9,350 per 28-day cycle. In clinical trials, the median duration of Stivarga treatment was 12 weeks, which would translate into a cost of about $28,000.

Stivarga's label includes a boxed warning about severe and fatal liver toxicity that occurred in clinical trials of Stivarga. As part of the approval, FDA is requiring Bayer to conduct postmarketing studies of Stivarga to evaluate the potential risk of QT/QTc interval prolongation, drug interactions with substrates of cytochrome P450 enzymes CYP2C8, CYP2C9 and CYP3A4, and impaired renal function. ...