Chad R. Ritch, MD, MBA, FACS, discusses how PSMA-PET informs staging, treatment planning, recurrence workup, and the interpretation of equivocal findings.
News|Articles|July 3, 2025
FDA news recap in urology for Q2 2025
Fact checked by: Patrick Campbell
Here’s a look back at notable news between April and June 2025.
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The specialty of urology, following an eventful first quarter, had a busy Q2 with a flurry of FDA approvals (and 1 notable non-approval) ranging from benign prostatic hyperplasia (BPH) to urge incontinence to bladder cancer and prostate cancer.
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Michael S. Cookson, MD, MMHC, FACS, discusses how Anktiva’s expanded FDA approval may broaden bladder-preserving treatment options for BCG-unresponsive papillary-only NMIBC.
Jeffrey M. Spier, MD, discusses how fatigue may impact patient quality-of-life and when dose reduction may be an appropriate treatment strategy.
This approval expands the perioperative use of pembrolizumab plus enfortumab vedotin to all patients with MIBC, regardless of cisplatin eligibility.
The agency issued a PDUFA target action date of June 14, 2027.
Jeffrey M. Spier, MD, reviews evidence on ARPI dose reduction in prostate cancer and discusses monitoring treatment response, tolerability, and dose reescalation.
Jeffrey M. Spier, MD, discusses managing ARPI-related fatigue through dose adjustments, patient monitoring, and strategies to maintain treatment adherence.
Long-term QUILT-3.032 findings show durable responses with Anktiva plus BCG in BCG-unresponsive NMIBC, with an estimated 84.2% cystectomy-free survival at 3 years.
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