Patients with late-stage, metastatic colon cancer who have run out of treatment options will soon have a new drug available that might help.
The drug Stivarga was approved on Thursday under the Food and Drug Administration's "fast track" program, which speeds up approval for drugs that work significantly better than other available therapies or where no treatments exist at all.
According to a study of 760 patients with late-stage colon cancer, Stivarga helped patients in the treatment group live an average of 1.4 months longer than patients taking a placebo; and patients had less tumor growth in the time they were taking the drugs.
Despite its success the drug has many side effects, including fatigue, loss of appetite, diarrhea, mouth sores, weight loss, infection, high blood pressure and changes in voice volume. The FDA is also requiring the drug's manufacturer, Bayer HealthCare Pharmaceuticals, to include a warning label, alerting patients that fatal liver toxicity did occur in some study patients.