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Hutchmed China Ltd on Tuesday said Chinese regulators have accepted and granted priority review to its new drug application for savolitinib to treat certain patients with advanced gastric cancer, marking another regulatory step forward for the targeted therapy. The Hong Kong-based developer of treatments for cancer and immunological diseases said the China National Medical Products Administration has accepted the application for savolitinib to treat adults with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET amplification who have failed at least two prior systemic therapies. The application is supported by data from a phase II registration study in China, which met its primary endpoint of objective response rate as assessed by an independent review committee. Savolitinib had previously been granted breakthrough therapy designation for this indication in 2023. Hutchmed said savolitinib has the potential to become the first selective MET inhibitor approved in China for MET-amplified gastric cancer, a subset of the disease associated with particularly poor outcomes. The company estimates that MET amplification occurs in around 4% to 6% of gastric cancer cases, representing roughly 18,000 patients annually in China. Savolitinib is an oral, highly selective MET tyrosine kinase inhibitor being jointly developed by Hutchmed and AstraZeneca PLC. The drug is already approved in China for certain lung cancer indications and is marketed by AstraZeneca under the brand name Orpathys. It has been included in China’s national reimbursement drug list since 2023. Shares in Hutchmed were down 0.3% at 198.38 pence in London on Tuesday morning. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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