HUTCHMED's Savolitinib NDA accepted in China for gastric cancer with MET amplification. Built on positive Phase II data.
The NDA has received strong support backed by encouraging results from a Phase II registration study conducted in Chinese patients. This development comes after the drug was granted Breakthrough Therapy Designation in 2023. Key numbers from the study include a significant increase in overall response rate of 75% and a notable improvement in progression-free survival by 40%. These promising outcomes further underscore the potential of the drug in effectively treating the target patient population.
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