Top 5 urologic oncology headlines you missed in September 2025

September 2025 welcomed several notable stories in urologic oncology, highlighting the continued advances across the field as well as the persistent areas of unmet needs. In this monthly recap, Urology Times® rounds up the most important regulatory decisions, clinical trial milestones, and practice-changing developments from September 2025.

Scroll down for a look at the top stories that shaped the past month.

1. FDA approves gemcitabine intravesical system for BCG-unresponsive NMIBC

On September 9, 2025, Johnson & Johnson announced FDA approval of their gemcitabine intravesical system for patients with BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.¹ The approval was supported by data from the cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623), which showed a complete response (CR) rate of 82%. Further, 51% of patients remained in CR for at least 1 year.

2. CAN-2409 significantly improves disease-free survival in localized prostate cancer

Data from the phase 3 PrTK03 trial (NCT01436968) of CAN-2409 were recently presented at the American Society for Radiation Oncology 67th Annual Meeting in San Francisco, California.² Overall, data showed that the addition of CAN-2409 plus valacyclovir (prodrug) to standard-of-care radiotherapy significantly improved disease-free survival compared with placebo plus valacyclovir in patients with localized intermediate- to high-risk prostate cancer.

Candel Therapeutics is planning to submit a Biologics License Application for CAN-2409 in the fourth quarter of 2026.

3. FDA approves pembrolizumab for subcutaneous injection for solid tumors

On September 19, 2025, Merck announced FDA approval of subcutaneous pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex; Merck) for previously approved solid tumor indications of intravenous pembrolizumab in adult and pediatric patients (12 years or older).³ The approval was backed by data from the phase 3 MK-3475A-D77 trial (NCT05722015), in which the subcutaneous formulation of pembrolizumab demonstrated noninferior pharmacokinetics compared with the intravenous formulation in patients with treatment-naive metastatic non–small cell lung cancer.

4. ACS report shows prostate cancer remains a significant public health challenge

The American Cancer Society released its annual Prostate Cancer Statistics, 2025 report in September, which showed increasing incidence rates alongside slowing declines in mortality rates.⁴ The report also shed light on persistent racial disparities in prostate cancer burden.

5. Biparametric MRI is noninferior to multiparametric MRI for prostate cancer diagnosis

Results from the PRIME trial (NCT04571840) showed that abbreviated biparametric MRI was found to be noninferior to multiparametric MRI in the detection of clinically significant prostate cancer.⁵ Overall, clinically significant prostate cancer was detected in 29.2% of patients with biparametric MRI vs 29.6% of patients with multiparametric MRI (difference, −0.4; 95% CI, −1.2 to 0.4 percentage points; P = .50).

According to the authors, these findings suggest that biparametric MRI could become the new standard of care for prostate cancer diagnosis.

REFERENCES

1. U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. News release. Johnson & Johnson. September 9, 2025. Accessed October 1, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated

2. Gejerman G, Manzanera A, Wheeler T, et al. Phase 3, randomized, placebo controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer. Presented at: American Society of Radiation Oncology 67th Annual Meeting. September 27-October 1, 2025. San Francisco, California. Abstract 114

3. FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection. FDA. September 19, 2025. Accessed October 1, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection

4. Kratzer TB, Mazzitelli N, Star J, et al. Prostate cancer statistics, 2025. CA: A Cancer Journal for Clinicians. 2025. doi:10.3322/caac.70028

5. Ng ABCD, Asif A, Agarwal R, et al. Biparametric vs multiparametric MRI for prostate cancer diagnosis: The PRIME diagnostic clinical trial. JAMA. 2025 Sep 10:e2513722. doi:10.1001/jama.2025.13722