The European Medicines Agency (EMA) has validated and accepted Chinese HUTCHMED Limited’s 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, Hutchmed said.
According to Hutchmed, 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‑p and SANET‑ep, both previously reported in The Lancet Oncology), along with existing data from surufatinib in U.S. extra-pancreatic and pancreatic NET patients, could form the basis to support a MAA. The submission follows the acceptance of a new drug application with the U.S. Food and Drug Administration, 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 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.”