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 FDA has approved Lynparza® for use in combination with bevacizumab as first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer
Amgen and Allergan announced that their biosimilar candidate ABP 215 met its primary and secondary endpoints in a Phase 3 study evaluating its efficacy and safety compared with Avastin (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).
Doctors may be able to identify which HER2-negative breast cancer patients will respond to treatment and which patients should switch to an alternative treatment.
Ophthalmic injections of bevacizumab exhibited no greater risk of endophthalmitis than injections of ranibizumab, according to a new study published in JAMA Ophthalmology.
Adding bevacizumab (Avastin) to standard chemotherapy and radiation treatment does not improve survival for patients with newly diagnosed glioblastoma, an often deadly brain cancer, researchers reported.