EMA validates HUTCHMED MAA for neuroendocrine tumour drug

China-based biotech HUTCHMED has announced that the EMA has validated and accepted the Marketing Authorisation Application (MAA) for surufatinib, for the treatment of pancreatic and extra-pancreatic neuroendocrine tumours (“NETs”).

The submission of the MAA follows positive data from two Phase III trials in China, alongside existing data from trials in the US.

Dr Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said: “HUTCHMED’s novel oncology pipeline is making important progress globally and the EMA’s validation of surufatinib’s MAA, which we believe recognizes the scientific value of this submission package, follows the recent acceptance of the U.S. NDA by the FDA.

“With its launch earlier this year in China, surufatinib has given NET patients an important new therapeutic option and we now hope to soon be able to bring this important treatment to patients across the U.S. and Europe.”

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant.

It is estimated that there were 19,000 newly diagnosed cases of NET in the US in 2020, with rates across the EU believed to be similar. This is supported by an analysis of global epidemiologic trends, which also show growth in the incidence of NETs worldwide. NETs are associated with a relatively long duration of survival compared to other tumors, and as a result, there were approximately 140,000 patients living with NET in France, Germany, Italy, Spain, and the United Kingdom in 2020.

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumour-associated macrophages, promoting the body’s immune response against tumour cells.

The unique dual mechanism of action in surufatinib may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumour effects.

Kat Jenkins