Hutchmed announced that the European Medicines Agency (EMA) has validated and accepted its marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs). The EMA’s validation confirms that the submission is sufficiently complete and that it is ready to commence the formal review process.
The submission follows scientific advice from the EMA’s Committee for Medicinal Products for Human Use (CHMP), from which it was concluded that the two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET-p1 and SANET-ep2, both previously reported in The Lancet Oncology), along with existing data from surufatinib in US extra-pancreatic and pancreatic NET patients, could form the basis to support a MAA. The submission follows the acceptance of a new drug application (NDA) with the US Food and Drug Administration (FDA), as announced on July 1, 2021.
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 US 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 US and Europe.”
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 tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
expeditious approvals from regulatory authorities, the safety profile of surufatinib, Hutchmed’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the Covid-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi, and Tyvyt as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Hutchmed’s filings with the US Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. Hutchmed undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.