HUTCHMED (China) Limited (HK:0013) has released an update.
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HUTCHMED (China) Limited has withdrawn its supplemental New Drug Application in China for fruquintinib, aimed at treating second-line advanced gastric cancer, following additional internal reviews and discussions with Chinese health authorities that highlighted the current data may not suffice for approval. Despite showing statistically significant improvements in progression-free survival, the data did not demonstrate a statistically significant improvement in overall survival as per the Phase III FRUTIGA trial. The company remains committed to evaluating future possibilities for fruquintinib’s use in gastric cancer treatment, as well as continuing its development for other cancers, including metastatic colorectal cancer.
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