Tablete trifluridin / tipiracil (LONSURF, Taiho Pharmaceutical Co., Ltd.) je 22. februarja 2019 odobrila Uprava za prehrano in zdravila za odrasle bolnike z metastatskim adenokarcinomom v želodcu ali prebavilih (GEJ), predhodno zdravljenih z vsaj dvema adenokarcinoma predhodne linije. , fiksna kombinacija trifluridina, zaviralca presnove nukleozidov, in tipiracila, zaviralca timidin-fosforilaze
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.
Mediana povprečnega preživetja pri bolnikih, zdravljenih z zdravilom Lonsurf, je bila 5.7 meseca (4.8, 6.2) in 3.6 meseca (3.1, 4.1) pri tistih, ki so se zdravili s placebom (razmerje nevarnosti: 0.69; 95% IZ: 0.56, 0.85; p = 0.0006). Pri bolnikih, randomiziranih v skupino Lonsurf (razmerje ogroženosti 0.56; 95-odstotni IZ: 0.46, 0.68; p <0.0001), je bilo tudi preživetje brez napredovanja bolezni daljše.
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.
Predpisani odmerek in urnik zdravila Lonsurf sta 35 mg / m2 / odmerek peroralno dvakrat na dan s hrano za vsako 28-dnevno obdobje od 1. do 5. dne in od 8. do 12. dne.
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.
