FDA Issues Approval for Colorectal Cancer Treatment Option

FDA Issues Approval for Colorectal Cancer Treatment Option
Image: Pixabay
September 22, 2015

The U.S. Food and Drug Administration (FDA) has approved a new medication to treat colorectal cancer.

Lonsurf, a pill that combines both trifluridine and tipiracil, received agency approval this week for use in patients with an advanced form of the disease. The oral medication is intended for individuals who have unsuccessfully completed chemotherapy and biological therapy.

"The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease," Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a written statement. "But there are many patients who still need additional options, and today's approval is a testament to the FDA's commitment to work with companies to develop new drugs in disease areas where unmet needs remain."

The efficacy of Lonsurf was established in a study of 800 individuals with advanced-stage colorectal cancer. Patients treated with Lonsurf lived an average of seven months, while those treated with the placebo only lived five months.

The most common side effects of treatment with Lonsurf are anemia, a decrease in infection-fighting white blood cells or blood platelets, physical weakness, extreme tiredness and fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain and fever.

According to the National Cancer Institute, colorectal cancer is the third most common non-skin cancer in men and women in the U.S. However, incidence has decreased over the last decade, due in part to regular screenings, such as colonscopies.