The U.S. Food and Drug Administration (FDA) has approved Stivarga® (regorafenib) for the treatment of patients with metastatic colorectal cancer that has progressed following previous treatment.
Colorectal cancer remains the second leading cause of cancer-related death in the United States. Metastatic colorectal cancer refers to cancer that has spread from the colon to distant sites in the body.
Targeted therapies are anticancer drugs that interfere with specific pathways involved in cancer cell growth or survival. Stivarga is a multi-kinase inhibitor that targets multiple biological pathways involved in cancer development. 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.
The approval was based upon the results of a single clinical study that included 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 treatment to manage the symptoms and side effects of cancer. Patients received treatment until their cancer progressed or side effects became unmanageable.
The results indicated that Stivarga prolonged life and delayed tumor growth. Patients in the Stivarga group lived a median of 6.4 months, compared to 5 months for patients in the placebo group. Patients in the Stivarga group experienced a delay in tumor growth for a median of 2 months, compared to a median of 1.7 months for patients in the placebo group.
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). 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.
FDA approves new treatment for advanced colorectal cancer. [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321271.htm