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FDA Approves Colorectal Cancer Treatment

Stivarga bottle (Bayer HealthCare Pharmaceuticals)

Stivarga bottle (Bayer HealthCare Pharmaceuticals)

The U.S. Food and Drug Administration approved the drug regorafenib to treat patients with metastatic colorectal cancer, where the cancer has progressed after treatment and spread to other parts of the body. Regorafenib is marketed under the brand name Stivarga by Bayer HealthCare Pharmaceuticals, in Wayne, New Jersey.

Stivarga blocks several enzymes that promote cancer growth. The drug was 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, which includes treatments to help manage side effects and symptoms of cancer. Patients received treatment until their cancers progressed or side effects became unacceptable.

The trial demonstrated improvement in overall survival and progression-free survival for those receiving Stivarga compared to those receiving the placebo in patients with metastatic colorectal cancer whose disease had progressed after approved standard therapies. Median overall survival was 6.4 months with Stivarga versus 5.0 months with placebo. Median progression-free survival was 2.0 months with Stivarga versus 1.7 months with placebo.

FDA approved Stivarga with a boxed warning noting that severe and fatal liver toxicity occurred in patients treated with Stivarga during the clinical studies. The most common side effects reported in patients treated with Stivarga are weakness or fatigue, loss of appetite, hand-foot syndrome (sometimes associated with chemotherapy), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia).

FDA says it cleared Stivarga after an expedited six-month review in a program for major advances in treatment or those that provide treatment when no adequate therapy exists. The agency says the review was completed one month ahead of the scheduled product’s prescription drug user fee goal date of 27 October 2012.

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