Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today that the oral anticancer drug "Lonsurf® combination tablet T15, T20" (nonproprietary names: trifluridine and tipiracil hydrochloride; development code: TAS-102) had received a National Health Insurance (NHI) reimbursement price listing. Lonsurf is scheduled for launch in Japan on May 26.
Lonsurf is an oral nucleoside antitumor agent developed by Taiho. Based on the results of Phase II clinical trial conducted in Japan, Taiho received approval on March 24, 2014 for the manufacture and marketing, initially in Japan, for the indications of "unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies)."
A global Phase III clinical trial (RECOURSE) in patients with refractory metastatic colorectal cancer (mCRC) demonstrated a significant improvement in overall survival (OS), the trial's primary endpoint, in the TAS-102 arm compared to the placebo arm. Based on these results, the company plans to pursue regulatory submissions in the United States and Europe.
Taiho is proud to make Lonsurf available to physicians in Japan as a new treatment option for patients with unresectable advanced or recurrent colorectal cancer refractory to standard therapies.
Lonsurf is an oral combination drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme thymidine phosphorylase.
The RECOURSE trial is a global, randomized, double-blind, placebo-controlled Phase III comparison trial evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The trial enrolled 800 patients who received at least two prior regimens of standard chemotherapies for mCRC and were refractory to, or failed, those chemotherapies. The trial was conducted in Japan, North America, Europe and Australia. Patients were randomly assigned to receive either TAS-102 or placebo in order to investigate the efficacy of TAS-102. The primary objective of the RECOURSE trial was improvement in overall survival (OS) versus placebo.
Product Summary (for the Japanese market)
Lonsurf® combination tablet T15, T20
Trifluridine and tipiracil hydrochloride
Indications & Efficacy
Unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies)
Use & Dosage
Usually, the initial dose (single dose) for adults is defined as the standard dose (approximately 35 mg/m2/dose of FTD) according to body surface area. Lonsurf is administered twice daily, after breakfast and after the evening meal, for five consecutive days, followed by a two-day rest. After repeating the above regimen twice, a 14-day rest follows, completing one course, which is then repeated. The dose can be decreased according to the patient's condition.
Date of manufacturing and marketing approval
March 24, 2014
Date listed in NHI reimbursement price listing
May 23, 2014
Date of initial marketing in Japan
May 26, 2014
Lonsurf combination tablet T15 PTP Packaging: 20 tablets (10 tablets x 2 sheets); 60 tablets (10 tablets x 2 x 3 sheets)
Lonsurf combination tablet T20 PTP Packaging: 20 tablets (10 tablets x 2 sheets); 60 tablets (10 tablets x 2 x 3 sheets)