On September 27, 2012, the US Food and Drug Administration announced that a drug called Stivarga was officially approved to treat patients with colorectal cancer that has become metastatic (or traveled to other parts of the body). 

The drug is being approved and released a whole month early of the prescription drug’s goal date, which was originally October 27, 2012.  The date was scheduled in order for a complete review of the drug. 

The drug went through an expedited review of six months.  The FDA only allows such expedited reviews when the drug offers a major advancement for treatment or there are no successful types of therapy currently on the market.  The drug is the first therapy that can block certain enzymes responsible for the growth of colorectal cancer. 

Richard Pazdur, M.D., the director of the Office of Hematology and Oncology Products, states: “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.” 

The drug comes with a boxed warning that states several patients died because of fatal liver toxicity during clinical studies.  The common side effects of this drug include the following: fatigue, loss of appetite, hand-foot syndrome, diarrhea, mouth sores, weight loss, infection, high blood pressure, and changes in the voice. 

Colorectal classifies as the third most common cancer for men and women in the United States according to the Centers for Disease Control and Prevention.  The National Institutes of health estimates that roughly 51,690 U.S. citizens will die because of colorectal cancer in 2012. 

The FDA reports that Zaltrap was also approved in August 2012 and combined with the Folfiri chemotherapy treatment to help treat metastatic colorectal cancer in adults.  The new drug Stivarga is manufactured by Bayer Healthcare Pharmaceuticals in Wayne, New Jersey.

Source: Food and Drug Administration