publication date: Oct. 26, 2018

Drugs & Targets

FDA accepts sNDA for Lonsurf for metastatic gastric/gastroesophageal junction adenocarcinoma; grants Priority Review

Taiho Oncology Inc. said FDA has accepted and granted priority review for the supplemental New Drug Application for Lonsurf (trifluridine/tipiracil, TAS-102) for previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.

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

The sNDA is based on data from the global, randomized, double blind pivotal phase III (TAGS) trial evaluating Lonsurf vs. 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, as well as continuing to demonstrate Lonsurf’s consistent safety and tolerability profile.

Full results from this study were recently presented at the European Society of Medical Oncology (ESMO) 2018 Congress in Munich and published simultaneously in The Lancet Oncology.

In the U.S., Lonsurf is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy.

TAGS (TAS-102 Gastric Study) is a Taiho-sponsored pivotal phase III, multinational, randomized, double-blind study evaluating trifluridine/tipiracil, also known as TAS-102, plus best supportive care vs. placebo plus BSC in patients with metastatic gastric cancer, including gastroesophageal junction cancer, refractory to standard treatments.

The primary endpoint in the TAGS trial is overall survival, and the main secondary endpoint measures include progression-free survival, and safety and tolerability, as well as quality … Continue reading FDA accepts sNDA for Lonsurf for metastatic gastric/gastroesophageal junction adenocarcinoma; grants Priority Review

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