The sBLA was based on efficacy and safety data from the KEYNOTE-A18 trial.
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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.
Lonsurf is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor.
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 phase 3 KEYNOTE-826 trial.