FDA Approves Bayer Drug for Stomach Cancer: Stivarga Comes to the U.S.

There may be a new way to treat a rare kind of stomach tumor in the United States. Bayer Ag and Onyx Pharmaceuticals Inc. won regulatory approval for a cancer drug designed to treat this kind of cancer.

The drug, called Stivarga, was first cleared by the Food and Drug Administration for patients whose gastrointestinal stromal tumors have progressed after trying standard therapies. It carries a label that warns of severe and fatal liver toxicity as one of the side effects.

Known generically as regorafenib, Stivarga was tested on 199 patients by Bayer before it won approval. Trials showed that patients who used the drug went an average of 3.9 months longer without tumor growth as opposed to patients that were treated with placebo.

Now, the FDA has also approved the drug for gastrointesintal stromal tumors (GIST). Patients diagnosed with GIST who took Stivarga were found to live 4.8 months without their disease worsening. That's compared with a mere .9 months for patients on placebo.

The rare cancer in the intestinal track is known as GIST. It can start anywhere in the gastrointestinal tract, though more than half of them start in the stomach. Most others start in the small intestine. Not all GISTs are cancerous, but the ones that are can cause severe issues. GIST mostly affects people older than 50, and as many as 5,000 people are diagnosed with the cancer every year.

The most common side effects for people taking Stivarga included liver damage, severe bleeding, blistering and peeling of skin, high blood pressure, heart attacks and perforations.

The treatment doesn't come cheap, either. It's priced at $9,350 for a 28-day treatment cycle. Other drugs approved to treat intestinal tumors include Gleevec and Stutent. Both are made by Pfizer Inc.