HONG KONG—Hutchmed (HKG: 0013) has announced its decision to proactively withdraw the new indication application for Fruquintinib in combination with paclitaxel for the second-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma in China. The company will now evaluate a new registration pathway following discussions with the National Medical Products Administration (NMPA).
The withdrawal comes after an internal reassessment of the data package, which Hutchmed believes is unlikely to support approval in China at this stage. The application was based on data from the FRUTIGA Phase III clinical trial, where several clinically meaningful endpoints showed statistically significant improvements, including one of the dual primary endpoints, progression-free survival (PFS), leading to a positive outcome announcement for the study.
While the second primary endpoint, overall survival (OS), showed an improvement, it did not reach statistical significance. Extensive subsequent analyses indicated that despite a high and unbalanced proportion of patients receiving subsequent anticancer treatments affecting the OS results, Fruquintinib combined with paclitaxel demonstrated meaningful clinical benefits and a favorable OS trend across a range of models.
The safety profile of Fruquintinib in combination with paclitaxel remained tolerable, with no new safety signals observed. However, communications with the Center for Drug Evaluation (CDE) and its external committee members clarified that the current understanding and interpretation of the OS results are insufficient to support the approval of the new indication application, necessitating further work.
Fruquintinib has already been approved in China, the U.S., and Europe for the treatment of previously treated metastatic colorectal cancer patients, with additional applications underway in over a dozen countries and regions. The drug exerts its antitumor effect by blocking tumor angiogenesis, as a selective oral inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, which play a key role in the growth of various solid tumors, including gastric cancer.- Flcube.com
