The IMbrave050 study included 662 patients with HCC at high risk for recurrence after surgical resection or ablation with curative intent.
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The approval was based on data from the SORAYA trial.
Alymsys is a vascular endothelial growth factor inhibitor.
Vegzelma is a vascular endothelial growth factor inhibitor.
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.