26 October 2018 - Taiho Pharmaceutical today announced that the United States FDA has accepted and granted priority review for the supplemental new drug application submitted by its U.S. subsidiary Taiho Oncology for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastro-oesophageal junction. 

The FDA has provided an anticipated Prescription Drug User Fee Act action date of 24 February 2019.

The sNDA is based on data from the global, randomised, double blind pivotal Phase III (TAGS) trial evaluating Lonsurf versus placebo and best supportive care in patients with pretreated metastatic gastric/gastro-oesophageal junction (GEJ) 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 consistently supported the overall survival results, as well as continuing to demonstrate Lonsurf’s consistent safety and tolerability profile. Full results from this study were presented on October 21 as an oral presentation at ESMO 2018 Congress in Munich and published simultaneously in The Lancet Oncology.

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