Priority review completed one month ahead of goal date
Silver Spring, Maryland–(ENEWSPF)–September 27, 2012. The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).
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 that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.
Stivarga is being approved one month ahead of the product’s prescription drug user fee goal date of Oct. 27, 2012, the date the agency was scheduled to complete review of the drug application.
“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 Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.
According to the Centers for Disease Control and Prevention, 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. The National Institutes of Health estimates 143,460 Americans will be diagnosed with colorectal cancer, and 51,690 will die from the disease in 2012.
The safety and effectiveness of Stivarga were evaluated in a single 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 includes treatments to help manage side effects and symptoms of cancer. Patients received treatment until their cancers progressed or side effects became unacceptable.
Study results showed patients treated with Stivarga plus BSC lived a median of 6.4 months compared to a median of five months in patients treated with placebo plus BSC. Results also showed patients treated with Stivarga plus BSC experienced a delay in tumor growth (progression-free survival) for a median of two months compared to a median of 1.7 months in patients receiving placebo plus BSC.
Stivarga is being approved with a Boxed Warning alerting patients and health care professionals 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 include 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).
In August 2012, the FDA approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with metastatic colorectal cancer.
Stivarga is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J. Zaltrap is marketed by Bridgewater, N.J.-based sanofi-aventis.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.