FDA Approves Trifluride Plus Tipiracil for Advanced Colorectal Cancer

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The FDA has approved trifluride plus tipiracil (Lonsurf) for treatment of advanced colorectal cancer previously treated with chemotherapy.
The FDA has approved trifluride plus tipiracil (Lonsurf) for treatment of advanced colorectal cancer previously treated with chemotherapy.

The U.S. Food and Drug Administration (FDA) has approved trifluride plus tipiracil (Lonsurf), a single oral medication, for the treatment of patients with advanced colorectal cancer who have been previously treated with chemotherapy and biologic therapy.1

“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

“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 American Cancer Society estimates that there will 132,700 new cases of colorectal cancer in the United States in 2015 and is estimated to cause 49,700 deaths during 2015, making it the second-leading cause of cancer-related deaths in the United States for men and women combined.

Approval is based on the findings of an international, double-blind study that evaluated the efficacy and safety of trifluride plus tipiracil in 800 patients with previously treated metastatic colorectal cancer.

Results showed that average overall survival was 7.1 months with trifluride plus tipiracil compared with 5.3 months with placebo. On average, time to disease progression was 2 months for those receiving trifluride plus tipiracil vs 1.7 months for those receiving placebo.

In regard to safety, the most common adverse events associated with the combination pill are anemia, neutropenia, thrombocytopenia, physical weakness, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever.

RELATED: Immune Response to Chemo Improves PFS in Colorectal Cancer Liver Metastases

Clinicians are advised to obtain complete blood cell counts prior to initiating each cycle of trifluride and tipiracil and to monitor patients throughout treatment for myelosuppression. The FDA also recommends that health care providers advise women of the potential risks of taking trifluride and tipiracil while pregnant and to discourage women from breastfeeding while on treatment.


  1. FDA approves new oral medication to treat patients with advanced colorectal cancer [news release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncPressA/ucm463650.htm. Updated September 22, 2015. Accessed September 22, 2015.

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