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
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.
Pembrolizumab plus chemotherapy with or without bevacizumab could be a new standard of care for first-line therapy in metastatic cervical cancer.
There was no improvement in overall survival with bevacizumab.