The Food and Drug Administration has approved Taiho’s trifluridine/tipiracil combinationfor adult patients with either gastric or gastroesophageal junction adenocarcinomas. Specifically, these patients will have been previously treated with at least two lines of chemotherapy that included fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, according to a from the company.
The approval was based on the TAGS trial, which was a global, randomized, phase 3 study that evaluated Lonsurf plus best supportive care versus placebo plus best supportive care. The trial demonstrated prolonged overall survival with the drug combo, compared with that seen with placebo, and thereby met its primary and secondary endpoint. The safety profile seen in the trial was consistent with what’s previously been seen with the drug. Results from this trial were published in .
Warnings and precautions for the drug combination include severe myelosuppression and embryo-fetal toxicity, as well as fatigue, nausea, diarrhea, infections, pyrexia, alopecia, and others. The full prescribing information can be found on the Taiho.