Lonsurf is approved by FDA for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma


Share This Post

Trifluridine/tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.) were approved by the Food and Drug Administration on February 22, 2019 for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior line adenocarcinomas, a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor

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.

The median average survival for patients treated with Lonsurf was 5.7 months (4.8, 6.2) and 3.6 months (3.1, 4.1) for those treated with placebo (hazard ratio: 0.69; 95% CI: 0.56, 0.85; p=0.0006). In patients randomized to the Lonsurf arm (hazard ratio 0.56; 95 percent CI: 0.46, 0.68; p<0.0001), progression-free survival was also longer.

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.

The prescribed dosage and schedule for Lonsurf is 35 mg/m2/dose orally twice daily with food for each 28-day period on Days 1 through 5 and Days 8 through 12.

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.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

The future of gene therapy for genetic disorders

Unlocking the genetic code: The future of gene therapy for genetic disorders

Gene therapy has typified the revolution in medicine that gives hope to various genetic disorders. This advanced treatment stops, and sometimes even reverses, the progress of a disease by the direct repair and replacement of defective genes. Trials and ethical dilemmas aside, this talent for transformation puts gene therapy right at the threshold of new frontiers in genetic medicine where inherited diseases might be eradicated altogether someday.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, Gene therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) CAR T-Cell therapy
2) Gene therapy
3) Gamma-Delta T Cell therapy
4) TIL therapy
5) NK Cell therapy