Hutchmed gets CRL from the FDA for surufatinib

Chinese biotech Hutchmed (AIM; HCM) on Monday announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for surufatinib for the treatment of pancreatic (pNETs) and extra-pancreatic (non-pancreatic, epNETs) neuroendocrine tumors (NETs). Oddly, the news saw the firm’s shares jump as much as 6%, but they closed London trading up a modest 0.4% at 246.90 pence.

The FDA determined that the current data package, based on two positive Phase III trials in China and one bridging study in the USA, does not support an approval in the US at this time. The CRL indicated that a multi-regional clinical trial (MRCT) is required for US approval.

The safety and efficacy of surufatinib, an oral inhibitor of angiogenesis and immune modulation, was demonstrated in the SANET-p and SANET-ep studies, two randomized double-blind Phase III trials in patients with advanced pNETs and epNETs conducted in China. Results of a Hutchmed-sponsored bridging study conducted in the USA suggest similar safety and efficacy to the SANET study population in China. Surufatinib was approved in China for the treatment of pNETs and epNETs in June 2021 and December 2020, respectively.