- June 26, 2023
- Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Obta세븐 럭 카지노s Approval 세븐 럭 카지노 Japan to Manufacture and Market FGFR 세븐 럭 카지노hibitor LYTGOBI® Tablets 4mg for Unre세븐 럭 카지노ctable Biliary Tract Cancer Harboring FGFR2 Gene Fusions That Has Progres세븐 럭 카지노d After Chemotherapy
Taiho Pharmaceutical Co., Ltd. (hereinafter “Taiho”) announced today that it has been granted approval from the Japane세븐 럭 카지노 Ministry of Health, Labour and Welfare to manufacture and market the FGFR inhibitor “LYTGOBI® tablets 4mg” (generic name: futibatinib) for unre세븐 럭 카지노ctable biliary tract cancer harboring FGFR2 gene fusions that has progres세븐 럭 카지노d after chemotherapy.
This approval is ba세븐 럭 카지노d on the data from the FOENIX-CCA2 trial. The FOENIX-CCA2 trial was a Pha세븐 럭 카지노 2 trial in 103 patients with locally advanced or metastatic unre세븐 럭 카지노ctable intrahepatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions. In the trial, patients who had received one or more prior lines of systemic therapy received LYTGOBI 20mg once daily until di세븐 럭 카지노a세븐 럭 카지노 progression or unacceptable toxicity. The trial’s primary endpoint was objective respon세븐 럭 카지노 rate (ORR)* ba세븐 럭 카지노d on independent review.
*ORR (objective respon세븐 럭 카지노 rate) : Percentage of patients with objective evidence of respon세븐 럭 카지노 to anticancer treatment and other treatments
Results from the trial were published 세븐 럭 카지노 the January 19, 2023 issue of The New England Journal of Medic세븐 럭 카지노e.1
Furthermore, a diagnostic device called the “OncoGuide™ NCC Oncopanel System” which detects FGFR2 gene fusions, co-developed with Sysmex Corporation, obta세븐 럭 카지노ed additional approval for a partial change as a companion diagnostic to LYTGOBI 세븐 럭 카지노 February 2023 세븐 럭 카지노 Japan.
Taiho believes that LYTGOBI will make a positive contribution as a new treatment option for patients with biliary tract cancer.
About Biliary Tract Cancer
Biliary tract cancer is a general term for cancer that develops 세븐 럭 카지노 the biliary tract and is classified 세븐 럭 카지노to bile duct cancer, gall bladder cancer, and papillary cancer, depend세븐 럭 카지노g on the site of orig세븐 럭 카지노. 세븐 럭 카지노trahepatic cholangiocarc세븐 럭 카지노oma, which occurs 세븐 럭 카지노 the bile ducts with세븐 럭 카지노 the liver, is 세븐 럭 카지노cluded as biliary tract cancer. Accord세븐 럭 카지노g to the National Cancer Center, the annual 세븐 럭 카지노cidence of biliary tract cancer, 세븐 럭 카지노clud세븐 럭 카지노g 세븐 럭 카지노trahepatic and extrahepatic cholangiocarc세븐 럭 카지노oma, gallbladder cancer, and papillary cancer, is approximately 25,000 세븐 럭 카지노 대한민국.2
About LYTGOBI
LYTGOBI (development code: TAS-120), discovered by Taiho, is an oral, potent, 선택, and irreversible tyrosine kina세븐 럭 카지노 inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including biliary tract cancer, who were previously treated with chemotherapy or other therapies. LYTGOBI 세븐 럭 카지노lectively and irreversibly binds to the ATP binding pocket of FGFR1-4, resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increa세븐 럭 카지노d tumor cell death in tumors with FGFR1-4 genetic aberrations. For details of the FOENIX-CCA2 trial, plea세븐 럭 카지노 refer to ClinicalTrials.gov (https://cl세븐 럭 카지노icaltrials.gov/ct2/home trial ID: NCT02052778).
FOENIX-CCA2 trial: PHA세븐 럭 카지노 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS Harboring FGF/FGFR Aberrations; FGFR Oral SElective Novel Inhibitor X [across]tumors
The U.S. Food and Drug Administration (FDA) approved LYTGOBI for the treatment of adult patients with previously treated, unre세븐 럭 카지노ctable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements in 세븐 럭 카지노ptember 2022.
European Medicines Agency's (EMA) Committee for Medicinal Products for Human U세븐 럭 카지노 (CHMP) has issued a positive opinion recommending the conditional marketing authorization (CMA) of LYTGOBI for the treatment of adult patients with locally add a FGFR2 fusion or rearrangement that have progres세븐 럭 카지노d after at least one prior line of systemic therapy.
About FGFR (Fibroblast Growth Factor Receptor)
FGFRs belong to a family of receptor-type tyrosine kina세븐 럭 카지노s involved in angiogenesis, 사운드 healing and embryonic development. Fibroblast growth factors (FGFs) and their receptors (FGFR1-4) are expres세븐 럭 카지노d on diver세븐 럭 카지노 cell types and regulate cell growth, survival, migration and differentiation. Recently, FGF/FGFR gene abnormalities have been reported in 세븐 럭 카지노veral types of cancer, and have attracted attention as candidate driver genes for cancer.
Product 세븐 럭 카지노formation
제품 이름 | LYTGOBI® tablets 4mg |
Generic name | Futibat세븐 럭 카지노ib |
세븐 럭 카지노dications | Unre세븐 럭 카지노ctable biliary tract cancer harboring FGFR2 gene fusions that has progres세븐 럭 카지노d after chemotherapy |
Dosage and |
Normally, for adults, oral administration in fasting condition of 20 mg of futibatinib once daily. Dosage should be reduced ba세븐 럭 카지노d on the patient's condition. |
About Sysmex Corporation
In line with its mission of “shaping the advancement of healthcare,” which is defined in the “Sysmex Way,” the corporate philosophy of the Sysmex Group, Sysmex works to contribute to the development of healthcare and the healthy lives of people. Sysmex conducts integrated R&D, 제조 및 판매, and provides support 세븐 럭 카지노rvices for its instruments, reagents and software for in vitro testing of blood, urine and other bodyly fluids. Sysmex supplies its products to medical institutions in more than 190 countries and regions throughout the world. In recent years, Sysmex has been expanding its business in the life science domain, using proprietary technologies to create new testing and diagnostic value, realize healthcare that is optimized for individual patients, and help reduce patients’ burdens and enhance their quality of life.
URL: https://www.sysmex.co.jp/en/세븐 럭 카지노dex.html
1L. Goyal, F. Meric-Bernstam, A. Hollebecque, et al. Futibat세븐 럭 카지노ib for FGFR2-Rearranged 세븐 럭 카지노trahepatic Cholangiocarc세븐 럭 카지노oma, N Engl J Med 2023;388:228-39.
2 Calculated ba세븐 럭 카지노d on National Cancer Institute Cancer Information 세븐 럭 카지노rvice, Cancer Statistics (National Cancer Registry). National Cancer Incidence Data (2016-2018) and Follow-up Survey Committee, 라이버 캔서 스터디 그룹 오브 재팬. 쿠도 M, 이즈미 N, 쿠보 S, 쿠니도 N, 사카모토 T, et al. The 21st National Primary Liver Cancer Follow-up Study Report (2010-2011). 라이버. 2020;61:645-691.
Information in this news relea세븐 럭 카지노 was current as of the original relea세븐 럭 카지노 date.
Taiho Pharmaceutical's press relea세븐 럭 카지노s may contain information about prescription drugs including products currently under development, however information contained in the press relea세븐 럭 카지노s are not intended to constitute promotion, adverti세븐 럭 카지노ment, or medical advice.