The U.S. Food and Drug Administration (FDA) recently granted approval for the drug Lonsurf, an oral medication to treat advanced colorectal cancer in patients who are no longer responding to other treatments.
The drug, which comes in a pill form, combines trifluridine and tipiraci.
“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said. “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 was the subject of an international study that involved 800 patients who had previously been treated for metastatic colorectal cancer. Subjects were administered Lonsurf along with supportive care or placebo plus best supportive care until their symptoms worsened or side effects became intolerable.
Results of the study showed patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo. The average time to disease progression was two months for the patients given Lonsurf as compared to 1.7 months for those given the placebo.
The most commonly reported side effects of Lonsurf were anemia, a decrease in white blood cells, weakness, fatigue, loss of appetite, diarrhea, vomiting, abdominal pain and fever.
Lonsurf is manufactured by Taiho Oncology, Inc. of Princeton, New Jersey.
Colorectal cancer drug approved by the FDA
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