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FDA Approves Combination Drug for Patients with Advanced Colorectal Cancer

National Cancer Institute (

October 14, 2015

by NCI Staff

On September 22, the Food and Drug Administration (FDA) approved a tablet that combines the drugs trifluridine and tipiracil hydrochloride (Lonsurf®) to treat patients with metastatic colorectal cancer whose disease progressed after standard treatments. The drug combination was previously known as TAS-102.

The safety and efficacy of trifluridine and tipiracil was tested in a randomized phase III clinical trial of 800 primarily Japanese patients with metastatic colorectal cancer, the results of which were published earlier this year in the New England Journal of Medicine.

Median overall survival in patients treated with Lonsurf was 7.1 months compared with 5.3 months for patients who received a placebo.

"The trifluridine and tipiracil combination offers a novel option for patients with advanced colorectal cancer who are not responding to other therapies," said Jo Anne Zujewski, M.D., of NCI's Cancer Therapy Evaluation Program, who was not involved in the study.

The most significant adverse reactions among patients receiving trifluridine and tipiracil were neutropenia, leukopenia, and febrile neutropenia. Because of the potential for these adverse reactions, the drug's label warns that patients with kidney problems should not take this drug.

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