Hutchmed withdraws NDA in China for fruquintinib in combination with paclitaxel

Hutchmed announced that it has voluntarily withdrawn its supplemental new drug application in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma and will evaluate a new route forward. Following an additional internal review of the current data package, in light of recent discussions with the National Medical Products Administration of China, Hutchmed has determined that the submission is unlikely to support an approval in China at this time. This supplemental NDA for fruquintinib was based on data from the Phase III FRUTIGA study due to statistically significant improvements in many clinically meaningful endpoints, including progression-free survival, which served as one of two primary endpoints. However, while an improvement was also observed in the second primary endpoint of median overall survival, it was not statistically significant. Extensive subsequent analyses conducted indicate that, although the high and imbalanced proportion of patients receiving subsequent antitumor therapies confounded the OS effect, fruquintinib plus paclitaxel demonstrated meaningful clinical benefit and favorable OS trends through a variety of models. Furthermore, no new safety signals were observed, and fruquintinib plus paclitaxel showed a tolerable safety profile. However, it became clear from dialogue with the Centre for Drug Evaluation of the NMPA and its external committee members that the current understanding and interpretation of the OS results could not serve as the basis of the supplemental NDA approval, and that further work needs to be undertaken.