Chad R. Ritch, MD, MBA, FACS, discusses how PSMA-PET informs staging, treatment planning, recurrence workup, and the interpretation of equivocal findings.
News|Articles|October 3, 2025
FDA news recap in urologic oncology for Q3 2025
Fact checked by: Patrick Campbell
Here’s a look back at notable news between July and September 2025.
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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).
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This approval expands the perioperative use of pembrolizumab plus enfortumab vedotin to all patients with MIBC, regardless of cisplatin eligibility.
The investigational HIF-2α inhibitor casdatifan demonstrated antitumor activity as monotherapy and in combination regimens across the ARC-20 platform study.
The agency issued a PDUFA target action date of June 14, 2027.
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Jeffrey M. Spier, MD, discusses managing ARPI-related fatigue through dose adjustments, patient monitoring, and strategies to maintain treatment adherence.
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