New Treatment for Advanced Colorectal Cancer Approved
The Food and Drug Administration (FDA) has approved the drug regorafenib (Stivarga) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body. Regorafenib blocks several enzymes that promote cancer cell growth.
The safety and effectiveness of regorafenib were evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Patients treated with regorafenib plus best supportive care (BSC) lived a median of 6.4 months, whereas patients treated with placebo plus BSC lived a median of 5 months. In addition, patients treated with regorafenib experienced a delay in tumor growth (progression-free survival) for a median of 2 months compared with a median of 1.7 months in patients in the placebo group.
Regorafenib is being approved with a boxed warning alerting patients and health care professionals that severe and fatal liver toxicity occurred in some patients treated with the drug during clinical studies. The most common side effects include weakness or fatigue, loss of appetite, hand-foot syndrome, diarrhea, mouth sores, weight loss, infection, high blood pressure, and changes in voice volume or quality.
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.