Navigating Recent Changes in Dosing Information: Dynamics of FDA-Approved Monoclonal Antibodies in Post-Marketing Realities.

Monoclonal antibodies (mAbs) are critical components in the therapeutic landscape, but their dosing strategies often evolve post-approval as new data emerge. This review evaluates post-marketing label changes in dosing information for FDA-approved mAbs from January 2015 to September 2024, with a focus on both initial and extended indications. We systematically analyzed dosing modifications, categorizing them into six predefined groups: Dose increases or decreases, inclusion of new patient populations by body weight or age, shifts from body weight-based dosing to fixed regimens, and adjustments in infusion rates.

Expression of Estrogen Receptor Beta Predicts Oncologic Outcome of pT3 Upper Urinary Tract Urothelial Carcinoma Better Than Aggressive Pathological Features.

Upper urinary tract urothelial carcinoma (UT-UC) is rare and treatment options or prognostic markers are limited. There is increasing evidence indicating that urothelial carcinoma may be an endocrine-related cancer. The aim of this study was to analyze the prognostic effect of estrogen receptor beta (ERβ) on the outcome of UT-UC.