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News From the Food and Drug Administration
November 3, 2015

One More Option for Advanced Colorectal Cancer

JAMA. 2015;314(17):1789. doi:10.1001/jama.2015.14009

A new medication that combines the drugs trifluridine and tipiracil has received FDA approval for use by patients with metastatic colorectal cancer who no longer respond to other treatments such as chemotherapy or biological therapy (http://1.usa.gov/1MofQMh).

Marketed as Lonsurf, the combination medication was evaluated in an international randomized trial involving 800 patients with previously treated metastatic cancer. Patients who received a placebo and supportive care lived an average of 5.3 months, compared with 7.1 months for those who received the trifluridine/tipiracil combination and supportive care. On average, the time to disease progression was 2 months for those who got the drug compared with 1.7 months for patients in the placebo group.

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