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 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.
Trifluridine had initially been developed in the 1950s but was abandoned because of a heavy side-effect burden.
"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, in a 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."
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.
The agency urged prescribers to obtain complete blood counts on patients being considered for Lonsurf and to monitor them during therapy for dangerous myelosuppression.
Lonsurf is made by Taiho Oncology of Princeton, N.J.