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A new drug has received fast-track approval to treat advanced colon cancer, the Food and Drug Administration announced Thursday. The drug, Stivarga, has been approved to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body, the FDA said.
The drug, manufactured by Bayer HealthCare Pharmaceuticals, works by blocking several enzymes that promote cancer growth. The FDA said it received a fast-track review designated for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.
In a study, patients taking the drug lived about six weeks longer than patients taking a placebo. "Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients' lives and is the second drug approved for patients with colorectal cancer in the past two months," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
Last month the FDA approved the Sanofi-Regeneron drug Zaltrap for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with metastatic colorectal cancer.