A post-hoc analysis of a randomized clinical trial comparing three anti-vascular endothelial growth factor (VEGF) agents, found that intravitreous aflibercept was associated with the greatest improvement in visual acuity (VA) over 2 years, for patients with diabetic macular edema (DME).
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The approval was based on evidence from animal study data, human pharmacokinetic and pharmacodynamics data, and clinical immunogenicity data which demonstrated Mvasi is a biosimilar to Avastin.
Mirvetuximuab soravtansine uses a humanized FRα-binding antibody to target antibody-drug conjugates specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.
REACH-2 was a randomized, double-blind, placebo-controlled trial that enrolled 292 patients with hepatocellular carcinoma (HCC) who were intolerant to, or had disease progression while on or following treatment with sorafenib and had a high alpha-fetoprotein (AFP-High) defined as AFP ≥400ng/mL.