New Indication for Lonsurf
February 22, 2019 – The U.S. FDA has approved a new indication for Lonsurf® (trifluridine/tipiracil) tablets, manufactured by Taiho Oncology. Under the new indication, the drug is approved to treat metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma in adult patients who have been previously treated with at least two lines of chemotherapy that include a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Treatment options are often limited for patients who have advanced, previously treated gastric or GEJ cancer. In clinical studies, patients who received Lonsurf had prolonged overall survival compared to patients who received a placebo. Recommended dosing is one 35 mg/m2 of body surface area dose taken twice daily with food Days 1-5 and Days 8-12 of each 28-day cycle.
Lonsurf originally received FDA approval in 2015 to treat metastatic colorectal cancer in adults who have received prior treatment.