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# Taiho Oncology sNDA for Lonsurf in Gastric Tumors
- URL: https://www.fdaweb.com/taiho-oncology-snda-for-lonsurf-in-gastric-tumors/
- Published: 2018-10-26T12:00:00.000Z
- Updated: 2026-09-15T00:40:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142680

FDA has accepted for priority review a Taiho Oncology supplemental NDA for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction. The agency has set a user fee review action target of 2/24/2019.

  
The submission is based on data from the global, randomized Phase 3 (TAGS) trial evaluating Lonsurf versus placebo and best supportive care in patients with heavily pretreated metastatic gastric/gastroesophageal junction adenocarcinoma that progressed or were intolerant to previous lines of therapy. The trial met its primary endpoint of prolonged overall survival and secondary endpoint measures of progression-free survival, the company says.