FDA Rejects New Drug Application for Surufatinib to Treat Advanced Neuroendocrine Tumors

Hutchmed’s submission was based primarily on two phase 3 trials conducted in China. Even though a bridging study conducted in the US that suggested safety and efficacy similar to that observed in the Chinese study population, FDA responded that a multiregional clinical trial “more representative of the US patient population and in accordance with US medical practice will be required” for resubmission.