FDA approves new colon cancer drug

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.

Colorectal cancer is the third most common cancer in men and in women and the third leading cause of cancer death in men and in women in the United States, according to the Centers for Disease Control and Prevention. More than 143,400 Americans will be diagnosed with colorectal cancer, and 51,690 will die from the disease in 2012, the government estimates.

Stivarga was evaluated in a study of 760 patients with previously treated metastatic colorectal cancer. Patients were randomly assigned to receive Stivarga or a placebo in addition to the best supportive care, which included treatments to help manage symptoms and side effects of cancer. Patients received treatment until their cancers progressed or side effects became unacceptable.

Patients treated with Stivarga and supportive care lived about 6.4 months, compared with five months for patients treated with placebo plus supportive care. Those who received Stivarga experienced a delay in tumor growth for about two months, compared with 1.7 months for patients receiving the placebo.

The Stivarga label warns that severe and fatal liver toxicity occurred in patients treated with Stivarga during clinical studies. The most common side effects reported in patients treated with Stivarga included weakness or fatigue, loss of appetite, hand-foot syndrome (also called palmar-plantar erythrodysesthesia), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia), the FDA said.

Pass it on: The FDA has approved a new drug to treat advanced colorectal cancer.