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.
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 5.0 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 2.0 months compared to a median of 1.7 months in patients receiving placebo plus BSC.