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FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and GEJ Adenocarcinoma


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ON FEBRUARY 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy. The previous chemotherapies included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate HER2-targeted therapy.

TAGS Trial

APPROVAL WAS based on the phase III TAGS trial (ClinicalTrials.gov identifier NCT02500043), an international, randomized, double-blind, placebo-controlled trial of 507 patients with metastatic gastric or GEJ adenocarcinoma previously treated with at least 2 prior lines of chemotherapy. Patients were randomly assigned 2:1 to receive trifluridine/tipiracil (n = 337), at 35 mg/m2 orally twice daily on days 1 to 5 and 8 to 12 of each 28-day cycle, with best supportive care or matching placebo (n = 170) with best supportive care until disease progression or unacceptable toxicity.

The median overall survival was 5.7 months for patients receiving trifluridine/tipiracil and 3.6 months for those receiving placebo (hazard ratio [HR] = 0.69; 95% confidence interval [CI] = 0.56–0.85; P = .0006). Progression-free survival was also longer in patients receiving trifluridine/tipiracil (HR = 0.56; 95% CI = 0.46–0.68; P < .0001).

In the TAGS trial, the most common adverse reactions or laboratory abnormalities (≥ 10% incidence) in patients treated with trifluridine/tipiracil occurring at a higher rate than in patients receiving placebo were neutropenia, anemia, nausea, decreased appetite, thrombocytopenia, vomiting, and diarrhea.

The recommended trifluridine/tipiracil dosage schedule is 35 mg/m2/dose orally twice daily with food on days 1 through 5 and days 8 through 12 of each 28-day cycle.

View the full prescribing information for trifluridine/tipiracil at accessdata.fda.gov.


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