Taiho Pharma ready to launch FGFR inhibitor Lytgobi in Japan

Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka Holdings (TYO: 4578), has announced that its FGFR inhibitor Lytgobi (futibatinib) has now been listed on the National Health Insurance (NHI) reimbursement price list, and the new product is scheduled for launch on September 7, 2023, in Japan.

Lytgobi, discovered by Taiho, 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 II trial, Lytgobi was approved in Japan in June 2023 for unresectable biliary tract cancer harboring FGFR2 gene fusions that has progressed after chemotherapy.

In September 2022, the US 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.