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.
Increased recurrence-free survival seen for patients with high-risk HCC following resection or ablation.
At the end of one year, likelihood of being weaned off treatment was higher for eyes treated with aflibercept versus bevacizumab
The sBLA was based on efficacy and safety data from the KEYNOTE-A18 trial.
Researchers say they have identified an unintended effect of Medicare’s 340B Drug Pricing Program; increases in spending for outpatient cancer treatments among patients with commercial insurance.
The IMbrave050 study included 662 patients with HCC at high risk for recurrence after surgical resection or ablation with curative intent.