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# Taiho Oncology NDA Approved for Lonsurf
- URL: https://www.fdaweb.com/taiho-oncology-nda-approved-for-lonsurf/
- Published: 2019-02-25T12:00:00.000Z
- Updated: 2026-09-15T01:07:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143459

FDA has approved a Taiho Oncology NDA for Lonsurf (trifluridine and tipiracil) for treating adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy. Approval was based on data from the global, randomized, Phase 3 TAGS trial evaluating Lonsurf plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated advanced gastric cancer or gastroesophageal junction adenocarcinoma following progression or intolerance to previous lines of standard therapy. The trial met its primary and secondary endpoints and demonstrated prolonged overall survival with Lonsurf versus placebo, and a safety profile consistent with prior experience with the drug.