The U.S. Food and Drug Administration (FDA) this week announced that it has approved a new drug for the treatment of colorectal cancer. According to the U.S. Centers for Disease Control and Prevention (CDC), colorectal cancer is the third most common cancer for both men and women, and the third leading cause of cancer deaths in the U.S.
The drug will be marketed under the name Stivarga by Bayer HealthCare Pharmaceuticals. It is approved to treat patients that have already been treated for colorectal cancer, but seen the disease metastasize and spread to other parts of the body. The treatment is a multi-kinase inhibitor that blocks specific enzymes that promote cancer growth.
“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 Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research.
Last month, a drug named Zaltrap was approved to treat adults with metastatic colorectal cancer.
Stivarga was approved one month ahead of when the FDA was expected to complete its review of the drug. The treatment was fast-tracked by the FDA under its priority review program, which expedites a six-month review for drugs that are "major advances" in treatment.
A study of 760 patients with metastatic colorectal cancer showed the effect of Stivarga. Studies showed that patients who received Stivarga saw a delay in tumor growth with a median of two months compared to those receiving a 1.7-month-median placebo. Overall, the patients treated with the drug lived a median of 6.4 months compared to placebo patients, who lived a median of five months.