Hutchmed (China) Ltd - Hong Kong-based biopharmaceuticals - The US Food & Drug Administration has rejected Hutchmed's surufatinib for treatment of pancreatic neuroendocrine tumours. In a complete response letter, the FDA says the current data package, based on two positive phase three trials in China and one bridging study in the US, does not support an approval in the US "at this time". The FDA said a multi-regional clinical trial of surufatinib required for US approval. Surufatinib was approved in China for the treatment of pNETs and extra-pancreatic neuroendocrine tumours in June 2021 and December 2020, respectively. Chief Executive Officer & Chief Scientific Officer Weiguo Su comments: "Although this decision from the FDA is disappointing, we remain confident about the clinical value of surufatinib for NET patients and committed to making surufatinib available to patients globally. We look forward to working with the agency to evaluate its feedback."
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By Tom Waite; thomaslwaite@alliancenews.com
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