HUTCHMED Withdrawn Its Supplemental New Drug Application For Fruquintinib Application For Advanced Gastric Cancer In China Following NMPA Discussions
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HUTCHMED has withdrawn its supplemental NDA for fruquintinib for advanced gastric cancer in China after discussions with the NMPA. Despite positive Phase III study results, the OS improvement was not statistically significant, leading to the withdrawal.
August 30, 2024 | 6:42 am
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HUTCHMED withdrew its supplemental NDA for fruquintinib in China due to non-significant OS results, despite positive PFS data. This may delay market entry and affect investor sentiment.
The withdrawal of the NDA is a setback for HUTCHMED as it delays the potential market entry of fruquintinib for advanced gastric cancer in China. The decision was based on the non-significant OS results, which are crucial for approval. This could negatively impact investor sentiment and the stock price in the short term.
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