Bayer's new cancer drug Stivarga has already added a notch to its belt. Cleared by the FDA last year to treat colorectal cancer, the drug is now approved as a treatment for a rare form of gastric cancer, gastrointestinal stromal tumors.
After a 6-month priority review, the FDA blessed Stivarga for patients with advanced GIST who have failed on other treatments. Bayer tested Stivarga, known generically as regorafenib, in 199 GIST patients who fit that profile. Stivarga patients went an average of 3.9 months longer without tumor growth than patients treated with placebo. Pfizer's ($PFE) Sutent and Novartis' ($NVS) Gleevec are also approved to treat GIST.
Stivarga has been riding in the fast lane for months. It won approval in metastatic colorectal cancer a month before its due date, and Bayer had shipments ready to go within 24 hours. Priced at $9,350 for a 28-day treatment cycle, the drug is co-marketed with Onyx Pharmaceuticals ($ONXX) in the U.S.
Onyx reported $8.2 million in royalties from the drug during the fourth quarter, its first on the market; at the agreed-upon 20%, those royalties indicate Q4 Stivarga sales of about $41 million. Bayer hasn't yet unveiled its own 2012 results, but the German drugmaker has said it's expecting Stivarga to hit the $1 billion blockbuster mark.
- see the FDA announcement
Timeline: Timeline on regorafenib (Stivarga) development
Special Report: Regorafenib – Top 10 Late-Stage Cancer Drugs – 2012