October 26, 2018 – FDA Accepts Supplemental New Drug Application for the Treatment of Metastatic Gastric/Gastroesophageal Junction (GEJ) Adenocarcinoma

Taiho Oncology announced that the FDA has granted priority review for the supplemental New Drug Application (sNDA) for LONSURF as new treatment for patients with previously treated advanced or metastatic gastric adenocarcinoma. The drug trial met its primary goal of prolonged overall survival and secondary endpoint measurements of progression-free survival (PFS) in addition to consistent safety and tolerability. LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidide phosphorylase inhibitor.

Clinical Trials
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