Japanese approval for Eisai’s Tasfygo and Rozebalamin
Japanese drugmaker Eisai (TYO: 4523) closed down 2.3% at 5,587 yen today, despite news of regulatory approvals for two of its drugs.
Eisai today revealed that it has obtained manufacturing and marketing approval for fibroblast growth factor receptor (FGFR) selective tyrosine kinase inhibitor Tasfygo (tasurgratinib succinate) tablets 35mg in Japan for the treatment of patients with unresectable biliary tract cancer with FGFR2 gene fusions or rearrangements that progressed after cancer chemotherapy.
In Japan, the drug has received orphan drug designation from the Ministry of Health, Labor and Welfare (MHLW), and the marketing authorization application was submitted in December 2023.
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