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FDA Approves Stivarga (Regorafenib) for Colorectal Cancer

Priority review completed 1 month ahead of goal date (Sept. 27)

The FDA announced on September 27 that it has approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and metastasized to other parts of the body.

Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program, which provides an expedited 6-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.

Stivarga was approved 1 month ahead of the product’s prescription drug user fee goal date of October 27, 2012 — the date the agency was scheduled to complete review of the drug application.

According to the Centers for Disease Control and Prevention (CDC), colorectal cancer is the third most common cancer in men and women and is the third leading cause of cancer death in men and women in the U.S. The National Institutes of Health (NIH) estimates that 143,460 Americans will be diagnosed with colorectal cancer and that 51,690 will die from the disease in 2012.

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

Patients treated with Stivarga plus BSC lived a median period of 6.4 months compared with a median period of 5.0 months in patients treated with placebo plus BSC. In addition, patients treated with Stivarga plus BSC experienced a delay in tumor growth (progression-free survival) for a median period of 2 months compared with a median period of 1.7 months in patients receiving placebo plus BSC.

Stivarga was approved with a boxed warning, which states that severe and fatal liver toxicity occurred in patients treated with the drug during clinical studies. The most common side effects reported in patients treated with Stivarga include weakness or fatigue, loss of appetite, hand-foot syndrome (palmar-plantar erythrodysesthesia), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia).

Stivarga is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J.

For more information, visit the FDA Web site.

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