The Agency could not approve the BLA due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
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Lonsurf is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor.
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.
The sBLA was based on efficacy and safety data from the KEYNOTE-A18 trial.
The IMbrave050 study included 662 patients with HCC at high risk for recurrence after surgical resection or ablation with curative intent.
The approval was based on data from the SORAYA trial.
The approval was based on data from the phase 3 KEYNOTE-826 trial.