第二款胆管癌靶向药物英菲格拉替尼获批上市

Infigratinib is an ATP-competitive, oral tyrosine kinase FGFR1~3 inhibitor, developed by the Oncology Department of the Swiss Novartis Pharmaceutical Group in cooperation with BridgeBio Pharma of the United States. It is used for the targeted treatment of locally advanced or metastatic cholangiocarcinoma. China LianBio Biopharmaceutical Company reached a cooperation agreement with BridgeBioPharma Company and its affiliated QED Therapeutics Company in August 2020, and obtained exclusive development and commercialization authorization for its capsules in Greater China. In August 2020, BridgeBio Pharma submitted a marketing application (NDA) to the FDA for infigratinib and its capsules for the treatment of second-line and late-line CCA. On December 1, 2020, the FDA accepted the company's NDA and granted priority review status and a real-time oncology review pilot program for review.

From May 29 to 31, 2020, at the 2020 American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago, the research and development company released some results of the Phase II clinical study of Infigratinib. This study is a multi-center, single-group clinical study, including 71 subjects, to evaluate the efficacy of Infigratinib as a third-line or above treatment for patients with FGFR2 fusion-positive cholangiocarcinoma. The patient received infigratinib, 125 mg orally once daily, for 21 consecutive days, with 7 days off treatment, a course of 28 days, until disease progression or unacceptable adverse reactions. The results showed that in the case of second-line treatment, the median progression-free survival (PFS) of patients was 4.63 months; the median PFS of patients who received third-line and above treatment with infigratinib was 6.77 months. The objective response rate (ORR) was 21.6% for patients receiving third-line or above treatment.

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