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Taiho Pharmaceutical Announces the Launch of FGFR inhibitor “LYTGOBI® in Japan

Wednesday, August 30, 2023

Taiho Pharmaceutical has introduced a new FGFR inhibitor LYTGOBI® tablets 4mg in Japan significant for the treatment of biliary tract cancer, specifically focusing on patients with FGFR genetic aberrations.

The approval of LYTGOBI in Japan is based on the results of the FOENIX-CCA2 phase 2 trial. It is intended for the treatment of unresectable biliary tract cancer with FGFR2 gene fusions that has progressed after chemotherapy. This approval provides a new treatment option for patients with this type of cancer, addressing an unmet medical need.

Biliary tract cancer encompasses different types of cancer originating in the biliary tract, including bile duct cancer, gall bladder cancer, and papillary cancer. Intrahepatic cholangiocarcinoma, which occurs within the liver's bile ducts, is also classified as biliary tract cancer.

In September 2022, the U.S. Food and Drug Administration (FDA) granted approval for LYTGOBI for the treatment of unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) harbouring FGFR2 gene fusions or other rearrangements. This marked a significant step in providing a targeted therapy for this specific type of cancer.

Furthermore, 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) who have FGFR2 fusions or rearrangements and have experienced disease progression after at least one prior line of systemic therapy.

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