Trifluridin / tipiracil tabletler (LONSURF, Taiho Pharmaceutical Co., Ltd.), 22 Şubat 2019 tarihinde Gıda ve İlaç Dairesi tarafından, daha önce en az iki önceki hat adenokarsinomu ile tedavi edilmiş metastatik mide veya gastroözofageal bağlantı (GEJ) adenokarsinomlu yetişkin hastalar için onaylanmıştır , bir nükleozid metabolik inhibitörü olan trifluridin ve bir timidin fosforilaz inhibitörü olan tipiracil'in sabit bir kombinasyonu
TAGS (NCT02500043), an international, randomized, double-blind, placebo-controlled trial, was accepted in 507 patients with metastatic gastric or GEJ adenocarcinoma who had previously undergone at least two previous chemotherapy lines of care. Patients were randomized 2:1 to receive Lonsurf (n=337) 35 mg/m2 orally twice daily on Days 1-5 and 8-12 of each 28-day cycle with best supportive care (BSC) or matching placebo (n=170) with BSC until disease progression or unacceptable toxicity.
Lonsurf ile tedavi edilen hastalar için medyan ortalama sağkalım, plasebo ile tedavi edilenler için 5.7 ay (4.8, 6.2) ve 3.6 aydır (3.1, 4.1) (tehlike oranı: 0.69;% 95 CI: 0.56, 0.85; p = 0.0006). Lonsurf koluna randomize edilen hastalarda (risk oranı 0.56; yüzde 95 CI: 0.46, 0.68; p <0.0001), ilerlemesiz sağkalım da daha uzundu.
In the TAGS report, neutropenia, anemia, nausea, reduced appetite, thrombocytopenia, vomiting and diarrhea were the most common adverse reactions or laboratory anomalies (approximately 10% incidence) in patients treated with Lonsurf, occurring at a higher rate than in patients treated with placebo.
Lonsurf için öngörülen dozaj ve program, Gün 35'den 2'e ve Gün 28'den 1'ye kadar her 5 günlük periyot için yemekle birlikte günde iki kez ağızdan 8 mg / m12 / dozdur.
View full prescribing information for LONSURF.
FDA granted this application priority review and orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
