Tablety trifluridín / tipiracil (LONSURF, Taiho Pharmaceutical Co., Ltd.) boli schválené Správou pre potraviny a liečivá 22. februára 2019 pre dospelých pacientov s adenokarcinómom s metastatickým adenokarcinómom žalúdka alebo gastroezofageálneho spojenia (GEJ), ktorí boli predtým liečení najmenej dvoma adenokarcinómami predchádzajúcej línie. , fixná kombinácia trifluridínu, nukleozidového metabolického inhibítora, a tipiracil, inhibítora tymidín fosforylázy
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.
Medián priemerného prežitia u pacientov liečených Lonsurfom bol 5.7 mesiaca (4.8; 6.2) a 3.6 mesiaca (3.1; 4.1) u pacientov liečených placebom (pomer rizika: 0.69; 95% IS: 0.56; 0.85; p = 0.0006). U pacientov randomizovaných do ramena s Lonsurfom (miera rizika 0.56; 95% CI: 0.46; 0.68; p <0.0001) bolo prežívanie bez progresie tiež dlhšie.
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.
Predpísané dávkovanie a schéma pre Lonsurf je 35 mg / m2 / dávka perorálne dvakrát denne s jedlom počas každého 28-dňového obdobia v 1. až 5. deň a 8. až 12. deň.
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.
