News Releases

Taiho Pharmaceutical Co., Ltd. (hereinafter “Taiho”) announced today that the FGFR inhibitor “LYTGOBI_® tablets 4mg” (generic name: futibatinib) has been listed on the National Health Insurance (NHI) reimbursement price list. The new product is scheduled for launch on September 7, 2023, in Japan.

LYTGOBI, discovered by Taiho, is an FGFR inhibitor. LYTGOBI binds covalently to FGFR 1, 2, 3 and 4, and inhibits FGFR-mediated signal transduction pathways selectively and irreversibly, resulting in reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations. Based on the results of the FOENIX-CCA2^* phase 2 trial, LYTGOBI was approved in Japan in June 2023 for unresectable biliary tract cancer harboring FGFR2 gene fusions that has progressed after chemotherapy.
^*FOENIX-CCA2 trial: PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS Harboring FGF/FGFR Aberrations; FGFR Oral SElective Novel Inhibitor X [across] tumors

In September 2022, the U.S. Food and Drug Administration (FDA) approved LYTGOBI for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements. In July 2023, the European Commission (EC) granted conditional marketing authorization for LYTGOBI monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Taiho believes that LYTGOBI will make a positive contribution as a new treatment option for patients with biliary tract cancer.

Biliary tract cancer is a general term for cancer that develops in the biliary tract and is classified into bile duct cancer, gall bladder cancer, and papillary cancer, depending on the site of origin. Intrahepatic cholangiocarcinoma, which occurs in the bile ducts within the liver, is included as biliary tract cancer. According to the National Cancer Center, the annual incidence of biliary tract cancer, including intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer, and papillary cancer, is approximately 25,000 in Japan.¹

FGFRs belong to a family of receptor-type tyrosine kinases involved in angiogenesis, wound healing and embryonic development. Fibroblast growth factors (FGFs) and their receptors (FGFR 1, 2, 3 and 4) are expressed on diverse cell types and regulate cell growth, survival, migration and differentiation. Recently, FGF/FGFR gene abnormalities have been reported in several types of cancer, and have attracted attention as candidate driver genes for cancer.

^**Administer to patients harboring FGFR2 gene fusions confirmed by testing conducted by an experienced pathologist or laboratory. For the testing, an approved in vitro diagnostic product or medical device should be used.

1) Calculated based on National Cancer Institute Cancer Information Service, Cancer Statistics (National Cancer Registry). National Cancer Incidence Data (2016-2018) and Follow-up Survey Committee, Liver Cancer Study Group of Japan. Kudo M, Izumi N, Kubo S, Kunido N, Sakamoto T, et al. The 21st National Primary Liver Cancer Follow-up Study Report (2010-2011). Liver. 2020;61:645-691.