The U.S. FDA announced the approval of Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.
“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, M.D., 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.”
Lonsurf is an oral medication intended to treat patients with advanced (metastatic) colorectal cancer who have been previously treated with chemotherapy and biological therapy.
The efficacy and safety of Lonsurf were evaluated in an international, randomized, double-blind study involving 800 patients with previously treated metastatic colorectal cancer. Patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo.
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