Regorafenib Approved for Advanced Colorectal Cancer


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The FDA recently approved regorafenib (Stivarga) to treat patients with metastatic colorectal cancer that has progressed after treatment.

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

Regorafenib is being 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.

“[Regorafenib] 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, MD, Director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.

Clinical Study

The safety and effectiveness of regorafenib were evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Patients were randomly assigned to receive regorafenib or placebo in addition to best supportive care. Patients received treatment until their cancers progressed or side effects became unacceptable.

Study results showed patients treated with regorafenib plus best supportive care lived a median of 6.4 months compared to a median of 5 months in patients treated with placebo plus best supportive care. Results also showed patients treated with regorafenib plus best supportive care experienced a delay in tumor growth (progression-free survival) for a median of 2 months compared to a median of 1.7 months in patients receiving placebo plus best supportive care.

Regorafenib is being approved with a Boxed Warning alerting patients and health-care professionals that severe and fatal liver toxicity occurred in patients treated with regorafenib during clinical studies. The most common side effects reported in patients treated with regorafenib include weakness or fatigue, loss of appetite, palmar-plantar erythrodysesthesia, diarrhea, mucositis, weight loss, infection, high blood pressure, and dysphonia.■



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