HUTCHMED (China) Limited (NASDAQ:HCM) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for Surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).
The regulatory agency determined that the current data package, based on two positive Phase III trials in China and one bridging study in U.S. does not support an approval in the United States at this time.
The Complete Response Letter (CRL) indicated that a multi-regional clinical trial (MRCT) is required for U.S. approval.
Dr Weiguo Su, Chief Executive Officer, commented: "Although this decision from the FDA is disappointing, we remain confident about the clinical value of surufatinib for NET patients and committed to making surufatinib available to patients globally. We look forward to working with the Agency to evaluate its feedback”.
HUTCHMED is trading down 14 percent at $13.01 in the pre-market session
