HUTCHMED Withdrawn Its Supplemental New Drug Application For Fruquintinib Application For Advanced Gastric Cancer In China Following NMPA Discussions

Author: Benzinga Newsdesk | August 30, 2024 02:41am

This supplemental NDA for fruquintinib was based on data from the Phase III FRUTIGA study, which was declared positive due to a statistically significant improvements in many clinically meaningful endpoints, including progression-free survival ("PFS"), which served as one of two primary endpoints. However, while an improvement was also observed in the second primary endpoint of median overall survival ("OS"), 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 (CDE) 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.

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