FDA news recap in urologic oncology for Q3 2025

The third quarter of 2025 saw a flurry of activity in the urologic oncology space. Bladder cancer continues to generate substantial buzz, particularly with the September FDA approvals of gemcitabine intravesical system (Inlexzo; formerly TAR-200) in BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex; Merck) for subcutaneous injection across all previously approved solid tumor indications of IV pembrolizumab in adults and adolescents (≥12 years).