Posted by Michael Wonder on 25 Feb 2019
FDA approves Taiho Oncology's Lonsulf (trifluridine/tipiracil) for adult patients with previously treated advanced gastric or gastro-esophageal junction (GEJ) Adenocarcinoma
25 February 2019 - Taiho Oncology today announced that the United States FDA has approved Lonsulf as a treatment for adult patients with metastatic gastric or gastro-esophageal 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 Lonsulf follows an FDA Priority Review designation and is based on data from a global, randomised, Phase III TAGS trial evaluating Lonsulf 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.
