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Trial Population Was One Reason For Pulling Surufatinib EU Filing

 
• By Neena Brizmohun

Hutchmed is in discussions with the European Medicines Agency on the path forward for its drug for advanced neuroendocrine tumors, whose marketing authorization application has now been withdrawn.

A path forward
Hutchmed is in discussions with EU and US regulators on the path forward • Source: Alamy

Hutchmed has withdrawn its EU marketing authorization application (MAA) for surufatinib, the company’s oral angio-immuno kinase inhibitor, which is approved as Sulanda in China for treating advanced neuroendocrine tumors but which the US regulator rejected in April this year.

The EU MAA was pulled after interactions between Hutchmed and reviewers at the European Medicines Agency suggested there was a low probability of a positive opinion on the MAA, the...

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