Posted by Michael Wonder on 18 Sep 2020
Chi-Med announces second NDA acceptance in China for surufatinib in pancreatic neuroendocrine tumours
17 September 2020 - Hutchison China MediTech today announces that its new drug application for surufatinib for the treatment of patients with advanced pancreatic neuroendocrine tumours has been accepted for review by the China National Medical Products Administration.
The new drug application is supported by data from the successful SANET-p study, a Phase 3 pivotal clinical trial of surufatinib in advanced neuroendocrine tumours – pancreatic patients in China for whom there is no effective therapy.
The study was terminated early following positive interim analysis completed in January 2020.
This is the second new drug submission acceptance for surufatinib. The first NDA for non-pancreatic NET was accepted by the NMPA in November 2019 and was granted priority review status in December 2019.
