FDA approves Lonsurf for gastric cancer

Taiho Pharmaceutical Co. Ltd. (Tokyo, Japan) said FDA approved Lonsurf trifluridine/tipiracil for adult patients with metastatic gastric or gastroesophageal junction 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.

The approval is based on data from the Phase III TAGS trial, in which Lonsurf prolonged overall survival (OS) compared with placebo in the third-line setting (see "Taiho's Lonsurf Meets OS Endpoint in Phase III for Gastric Cancer")...