FDA approves Lonsurf for metastatic gastric or gastroesophageal junction adenocarcinoma.- Taiho Oncology

Taiho Oncology announced that the FDA has approved Lonsurf (trifluridine + tipiracil) as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

The approval for Lonsurf follows an FDA Priority Review designation and is based on data from a global, randomized, Phase III TAGS trial evaluating Lonsurf plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated advanced gastric cancer or GEJ adenocarcinoma following progression or intolerance to previous lines of standard therapy. The trial met its primary and secondary endpoints demonstrating prolonged overall survival (OS) with Lonsurf versus placebo, and a safety profile consistent with prior experience with this drug.

Full results from the TAGS trial were presented at the European Society of Medical Oncology (ESMO) 2018 Congress with a simultaneous publication in The Lancet Oncology.

See "Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase III trial." Kohei Shitara et al. The Lancet Oncology October 21, 2018 DOI:https://doi.org/10.1016/S1470-2045(18)30739-3