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Trifluridine/tipiracil combination tablets FDA approved for metastatic gastric or GEJ adenocarcinoma
By: scienterrific | Last updated: 23 February 2019 | In: Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Oncology, Chemotherapy
Article Keywords
FDA, irinotecan, Lonsurf, Taiho Pharmacuetical, tipiracil, trifluridine
On 22 February 2019, the FDA approved the fixed combination tablets of the nucleoside metabolic inhibitor trifluridine plus the thymidine phosphorylase inhibitor tipiracil (Lonsurf®, Taiho Pharmaceutical) for the treatment of adult metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients pretreated with two or more prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan plus (when appropriate) HER2/neu-targeted therapy.1FDA website
TAGS
The international, randomised, double-blind, placebo-controlled TAGS (NCT02500043) trial randomised 507 metastatic gastric or GEJ adenocarcinoma patients 2:1 to receive trifluridine/tipiracil (N=337) plus best supportive care (BSC) or matching placebo (n=170) plus BSC. All patients had received at least two prior lines of chemotherapy. Treatment was until disease progression or unacceptable toxicity.
The progression-free survival (PFS) benefitted patient randomised to the active arm vs patients on placebo. The hazard ratio (HR) for PFS was 0.56 (95% CI: 0.46-0.68; P<0.0001). The median overall survival in patients treated with trifluridine/tipiracil measured 5.7 months (4.8-6.2) vs 3.6 months (3.1-4.1) in the placebo-arm (HR=0.69; 95% CI: 0.56-0.85; P=0.0006).
Safety
Common adverse reactions and laboratory abnormalities in ≥10% of patients treated with trifluridine/tipiracil and at with a higher rate when compared to patients receiving placebo included neutropenia, anaemia, nausea, decreased appetite, thrombocytopenia, vomiting, and diarrhoea.
Disclaimer
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2019 MediPaper Medical Communications Ltd.
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