FDA Grants Priority Review to TAS-102 for Gastric/GEJ Cancer

October 25, 2018 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for TAS-102 (trifluridine/tipiracil) for use in previously treated patients with advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction (GEJ). The sNDA is based on data from the phase III TAGS trial, in which TAS-102 reduced the risk of death by about one-third compared with placebo in patients with heavily pretreated … (leggi tutto)