What's next in urology — October 16, 2026

This edition covers what is coming in urology between mid-October 2026 and March 2027: two pending FDA decisions (muscle-invasive bladder cancer and metastatic castration-sensitive prostate cancer) and the three meetings where new data are expected. We include only milestones with a date verifiable in an official or primary source; efficacy figures come from company press releases, not yet from peer-reviewed publications.

1. Perioperative durvalumab + enfortumab vedotin in muscle-invasive bladder cancer (VOLGA)

[Pending regulatory decision] [USA; also under review in the EU and Japan] [Estimated date: Q4 2026, per AstraZeneca]
What it is: Priority-review sBLA for neoadjuvant durvalumab + enfortumab vedotin (3 cycles) followed by adjuvant durvalumab (9 cycles) in muscle-invasive urothelial carcinoma (T2–T4aN0/1M0 or T1N1M0) in patients ineligible for or declining cisplatin, who are cystectomy candidates. Open-label phase 3 VOLGA (NCT04960709), 695 patients randomized 1:1:1; per the company, the interim analysis showed significant improvement in event-free survival (primary endpoint) and overall survival versus cystectomy ± approved adjuvant therapy.
What problem it solves: Cisplatin-ineligible patients have historically had few neoadjuvant options and high recurrence after cystectomy. Today, in the US, the perioperative reference in this group is enfortumab vedotin + pembrolizumab, approved by the FDA on November 21, 2025 for cisplatin-ineligible patients (KEYNOTE-905/EV-303).
Critical take: Open-label, AstraZeneca-sponsored, no hazard ratios released yet; per AstraZeneca, the triplet arm with tremelimumab improved event-free survival but did not reach significance for overall survival at the interim analysis (favourable trend only); and enfortumab's cost limits applicability in our setting.
https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Perioperative-IMFINZI-durvalumab-plus-neoadjuvant-enfortumab-vedotin-granted-Priority-Review-in-the-US-for-patients-with-muscle-invasive-bladder-cancer.html
https://clinicaltrials.gov/study/NCT04960709
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2026/imfinzi-ev-improves-efs-os-in-bladder-cancer.html
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer

2. Talazoparib + enzalutamide in HRR-altered metastatic castration-sensitive prostate cancer (TALAPRO-3)

[Pending regulatory decision] [USA; also under EMA review] [Estimated date: last quarter of 2026, per Pfizer]
What it is: Priority-review sNDA based on the randomized, double-blind phase 3 TALAPRO-3 trial (NCT04821622), sponsored by Pfizer with Astellas: 599 men with metastatic castration-sensitive prostate cancer and homologous recombination repair (HRR) gene alterations, with up to 3 months of prior ADT (with or without an ARPI); comparator placebo + enzalutamide. Pfizer reports a 52% reduction in the risk of radiographic progression or death (rPFS, primary endpoint).
What problem it solves: HRR-altered tumors progress sooner despite ADT + ARPI. Today the standard is ADT + ARPI (± docetaxel); in the US, the FDA approved niraparib + abiraterone (with prednisone) on December 12, 2025 only for BRCA2 mutations (AMPLITUDE trial).
Critical take: rPFS is a surrogate endpoint and overall survival is immature (the company itself cautions it may not be met); the indication requires tumor or germline sequencing, which is scarce in our setting.
https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-priority-review-pfizers-talzenna-plus-xtandi
https://clinicaltrials.gov/study/NCT04821622
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration

3. Society of Urologic Oncology Annual Meeting (SUO 2026)

[Congress] [USA (San Diego)] [Confirmed date: December 2–4, 2026]
What it is: The 27th SUO annual meeting, a urologic oncology forum where updated analyses of intravesical and systemic therapies are often presented.
What problem it solves: Non-muscle-invasive bladder cancer is seeing a wave of new intravesical therapies after the BCG shortage, and longer follow-up is needed to know which ones keep their responses.
Critical take: The late-breaking program is not published; we do not anticipate specific results, and many data at this meeting come from single-arm phase 2 studies.
https://suonet.org/meetings/event-details.aspx?id=SUO2612

4. ASCO Genitourinary Cancers Symposium 2027

[Congress] [USA (San Francisco)] [Confirmed date: February 11–13, 2027]
What it is: ASCO's symposium on prostate, bladder, kidney and testicular cancers, at Moscone West.
What problem it solves: It is one of the main annual showcases for phase 3 genitourinary oncology trials; fuller data from trials now under regulatory review (VOLGA, TALAPRO-3) could be presented.
Critical take: A company presenting there is an expectation, not a public commitment; congress abstracts are no substitute for full publication.
https://moscone.com/events/american-society-clinical-oncology-gu-cancers-symposium-2027

5. 42nd Annual European Association of Urology Congress (EAU27)

[Congress] [Europe (Amsterdam)] [Confirmed date: March 19–22, 2027]
What it is: The EAU annual congress at RAI Amsterdam, covering all of urology (oncology, functional, stones, andrology, pediatrics).
What problem it solves: It is the reference meeting for European urologic practice; historically the annual EAU guidelines update is released around the congress.
Critical take: The EAU has not yet announced a date for the 2027 guidelines edition; we treat it as an expectation, not a fact.
https://eaucongress-new.uroweb.org/the-congress/announcing-eau27
https://uroweb.org/education-events/42nd-annual-eau-congress

*What's next in urology — October 16, 2026*

1. Muscle-invasive bladder cancer, cisplatin-ineligible: FDA decides on perioperative durvalumab + enfortumab (VOLGA) — Q4 2026.
2. HRR-altered metastatic castration-sensitive prostate cancer: FDA decides on talazoparib + enzalutamide (TALAPRO-3) — by end of 2026.
3. SUO 2026, San Diego — December 2–4, 2026.
4. ASCO GU 2027, San Francisco — February 11–13, 2027.
5. EAU27, Amsterdam — March 19–22, 2027.

Figures from company press releases; not yet peer-reviewed.

Full text and audio: https://boletinesmedicos.com/en/urology/2026-10-16-viene.html
MedBulletins · boletinesmedicos.com

What's next in urology (October 2026 – March 2027)

Two FDA decisions pending before year end:
• Perioperative durvalumab + enfortumab vedotin in cisplatin-ineligible muscle-invasive bladder cancer (VOLGA, 695 patients). Event-free and overall survival improved per the sponsor; hazard ratios not yet released.
• Talazoparib + enzalutamide in HRR-altered metastatic castration-sensitive prostate cancer (TALAPRO-3, 599 patients). 52% reduction in risk of radiographic progression or death; overall survival immature.

Plus three meetings to test press releases against data: SUO (Dec 2–4), ASCO GU (Feb 11–13) and EAU27 (Mar 19–22).

Item cards with official sources, critical take and audio: https://boletinesmedicos.com/en/urology/2026-10-16-viene.html

#Urology #BladderCancer #ProstateCancer #UroOncology #EvidenceBasedMedicine

What's next in urology: FDA decisions by end-2026 on durvalumab+enfortumab (bladder, VOLGA) and talazoparib+enzalutamide (HRR prostate, TALAPRO-3). Meetings: SUO Dec, ASCO GU Feb, EAU27 Mar. https://boletinesmedicos.com/en/urology/2026-10-16-viene.html