EMA validates Hutchmed's MAA for surufatinib

The European Medicines Agency has validated and accepted the marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs), submitted by China’s Hutchmed (Nasdaq: HCM).

The EMA's validation confirms that the submission is sufficiently complete and that it is ready to commence the formal review process, said Hutchmed, formerly known as Hutchison China MediTech or Chi-Med, whose shares were up 3.3% at $39.38 by mid-morning.

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 US extra-pancreatic and pancreatic NET patients, could form the basis to support an MAA.