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.
Your search for bevacizumab returned 25 results
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
Alymsys is a vascular endothelial growth factor inhibitor.
Vegzelma is a vascular endothelial growth factor inhibitor.
Outcomes at 2 years comparable among patients with diabetic macular edema receiving aflibercept monotherapy, bevacizumab first
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.
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.
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