CHMP recommends Lytgobi to treat locally advanced or metastatic cholangiocarcinoma
Taiho Pharmaceutical Co., Ltd. and its European subsidiary Taiho Oncology Europe GmbH announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization (CMA) of futibatinib (Lytgobi) for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma(CCA) with a fibroblast growth factor receptor 2(FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy
Each year, approximately 6,000-8,000 individuals in Europe are diagnosed with CCA, a rare cancer of the bile ducts of the liver, and approximately 0.3-6 people per 100,000 individuals live with CCA worldwide.
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