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FDA Approves New Drug for Advanced Colon Cancer

Article date: September 28, 2012

The US Food and Drug Administration (FDA) today approved Stivarga (regorafenib) to treat patients with metastatic colon or rectal cancer that has already been treated with several other drugs.

Stivarga was approved under the FDA’s priority review program for drugs that show promise against a serious disease. The drug was evaluated in a clinical study of 760 patients who had previously been treated for metastatic colon cancer. Patients treated with Stivarga lived an average 6.4 months, compared to 5 months for patients who received a placebo.

The drug works by blocking several enzymes in the body that help cancer cells grow. It’s the second drug approved for colon and rectal cancer in the past two months. The FDA approved Zaltrap (ziv-aflibercept) in August.

A warning to be included in the drug’s prescribing information states that severe and sometimes fatal liver toxicity occurred in some patients treated with Stivarga during the clinical study. Other side effects can include weakness or fatigue, loss of appetite, hand-foot rash, diarrhea, mouth sores, weight loss, infection, high blood pressure, and voice changes.

The drug is marketed by Bayer HealthCare Pharmaceuticals.

Reviewed by: Members of the ACS Medical Content Staff


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