From the AMA MEDPage Today WASHINGTON -- A cancer drug once discarded decades ago as excessively toxic has now been approved as part of a fixed-dose combination product for treating drug-resistant, advanced colorectal tumors.
The FDA announced Tuesday that the combination of trifluridine and tipiracil, with the brand name Lonsurf, could be marketed for the colorectal cancer indication. Trial results published in May had shown that the product extended median overall survival by about 2 months (7.1 months versus 5.3 months for placebo) in patients who had exhausted other treatment options.
Although adding tipiracil to trifluridine appears to have improved the benefit-risk balance, the combination still comes with a long list of adverse effects, including a range of hematologic deficiencies, extreme fatigue, decreased appetite, fever, and gastrointestinal disruptions, the FDA said.
Then the article stated that the FDA is commited to working with pharmetical companies
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September 2015