Lonsurf Gets New Indication for Recurrent, Metastatic Gastric and GEJ Cancers

The FDA granted a new indication to trifluridine/tipiracil (Lonsurf, Taiho Pharmaceutical) for adults with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Approval was based on TAGS, an international, randomized, double-blind, placebo-controlled trial in 507 patients with metastatic