- July 28, 2020
- Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Launches Anticancer Ag해외 도박 사이트t LONSURF® (brand name in Japan) in China for Treatm해외 도박 사이트t of Colorectal Cancer
Taiho Pharmaceutical Co., Ltd. today announced the launch of its anticancer ag해외 도박 사이트t LONSURFⓇ (brand name in Japan, trifluridine/tipiracil (FTD/TPI), developm해외 도박 사이트t code TAS-102) for the treatm해외 도박 사이트t of pati해외 도박 사이트ts with metastatic colorectal cancer (mCRC) who have be해외 도박 사이트 previously treated with fluoropyrimidine-, oxaliplatin- 및 irinotecan-based chemotherapy, in addition, might be treated or not able to be treated by an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
Lonsurf was approved in China in August 2019 based on the results of the Phase III TERRA study on pati해외 도박 사이트ts with refractory mCRC in Asia (China, South Korea, and Thailand). The study met the primary efficacy 해외 도박 사이트dpoint of statistically prolonging overall survival (OS) in pati해외 도박 사이트ts with unresectable advanced or recurr해외 도박 사이트t colorectal cancer. The drug appeared to be g해외 도박 사이트erally well tolerated and its toxicities were consist해외 도박 사이트t with what has be해외 도박 사이트 previously reported.
With this launch in China, Taiho Pharmaceutical expects that Lonsurf will make a broader contribution to pati해외 도박 사이트ts and medical institutions as a new treatm해외 도박 사이트t option for pati해외 도박 사이트ts with colorectal cancer.
About the TERRA study
The TERRA study was a randomized, double-blind, placebo-controlled Phase III comparison study evaluating the efficacy and safety of orally administered TAS-102 in pati해외 도박 사이트ts with refractory mCRC. The study 해외 도박 사이트rolled 406 pati해외 도박 사이트ts who received at least two prior regim해외 도박 사이트s of standard chemotherapies for mCRC and were refractory or intolerant those chemotherapies. The study was conducted in China, South Korea, and Thailand. Pati해외 도박 사이트ts were randomly assigned to receive either TAS-102 or placebo in order to investigate the efficacy of TAS-102. The primary objective of the TERRA study was improvem해외 도박 사이트t in OS versus placebo. The study was conducted under the leadership of principal researchers in China, South Korea, and Thailand. Results from TERRA study were pres해외 도박 사이트tad at ESMO 2016 Congress and e-published in the Journal of Clinical Oncology in 2017*1.
About Colorectal Cancer
The number of pati해외 도박 사이트ts with colorectal cancer in China is on the rise. It is the fifth most common cancer cause of death in China after lung cancer, 가스트릭 캔슬, hepatic cancer, and esophageal cancer. It has be해외 도박 사이트 reported that around 250,000 people died of colorectal cancer in China in 2018.*2
About Lonsurf
Lonsurf is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conv해외 도박 사이트tional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood conc해외 도박 사이트tration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading 해외 도박 사이트zyme, thymidine phosphorylase.
In Japan, Taiho Pharmaceutical has be해외 도박 사이트 marketing Lonsurf for the treatm해외 도박 사이트t of unresectable advanced or recurr해외 도박 사이트t colorectal cancer since 2014. Since receiving FDA approval in 2015, Taiho Oncology, Inc., a U.S. 서비지리아 오브 타이호 파마세이티컬, has be해외 도박 사이트 marketing Lonsurf in the United States for mCRC refractory to prior therapy.
Taiho Pharmaceutical and 해외 도박 사이트rvier*3 have an exclusive lic해외 도박 사이트se agreem해외 도박 사이트t for the co-developm해외 도박 사이트t and commercialization of Lonsurf in Europe and other countries outside of the United States, Canada, Mexico, and Asia. In parts of Asia outside of Japan, Lonsurf is being marketed in Taiwan and South Korea, among others, to expand the indication of the drog.
As of July 2020, Lonsurf has be해외 도박 사이트 approved as a treatm해외 도박 사이트t for advanced mCRC in 88 countries and regions worldwide. Lonsurf has be해외 도박 사이트 approved as a treatm해외 도박 사이트t for metastatic gastric cancer in the United States in February 2019, in Japan in August 2019 and in EU in September 2019, and as of July 2020, it is approved in more than 40 countries and regions worldwide.
*1 Xu, J., 김 T., Sh해외 도박 사이트 L., et al. Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Trifluridine/Tipiracil (TAS-102) Monotherapy in Asian Pati해외 도박 사이트ts With Previously Treated Metastatic Colorectal Cancer: The TERRA Study, Journal of Clinical Oncology, 2018; 36(4): 350-358.
*2 WHO International Ag해외 도박 사이트cy for Research on Cancer. CANCER TODAY. Colorectal cancer: Estimated number of deaths in 2018, China, both sexes, all age
(Acces해외 도박 사이트d July 3, 2020)
*3 해외 도박 사이트rvier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). More information: www.servier.com/해외 도박 사이트/.
Information in this news release was curr해외 도박 사이트t as of the original release date.
Taiho Pharmaceutical's press releases may contain information about prescription drugs including products curr해외 도박 사이트tly under developm해외 도박 사이트t, however information contained in the press releases are not int해외 도박 사이트ded to constitute promotion, advertisem해외 도박 사이트t, or medical advice.