HUTCHMED Withdraws Fruquintinib Application for Second-Line Gastric Cancer Treatment in China

HUTCHMED has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma.
The decision was made after discussions with the National Medical Products Administration of China (NMPA) and an internal review, which indicated that the current data package would not support approval at this time.
The application was based on data from the Phase III FRUTIGA study, which showed statistically significant improvements in progression-free survival (PFS) but not in median overall survival (OS).
Despite the withdrawal, HUTCHMED remains optimistic about the potential of fruquintinib in treating gastric cancer and plans to investigate further.