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).

With Q3 behind us, here’s a look back at notable news between July and September.

FDA clears image-guided navigation platform for focal therapy in prostate cancer

Date: July 23, 2025

Indication: Prostate cancer image guidance

Summary: The FDA has granted 510(k) clearance to an updated version of the Philips UroNav System, a platform designed to advance image-guided navigation in prostate cancer care. The upgraded system introduces an advanced annotation workflow that integrates pre-procedural imaging with real-time intra-procedural ultrasound, offering clinicians a more precise, dynamic view of target areas during focal therapy.¹

FDA grants de novo authorization to ArteraAI Prostate

Date: August 13, 2025

Indication: Non-metastatic prostate cancer risk stratification

Summary: The FDA has granted de novo authorization to ArteraAI Prostate, making it the first AI-powered tool cleared to prognosticate long-term outcomes in patients with localized prostate cancer. Developed with multimodal AI technology, the platform analyzes both biopsy images and clinical data to estimate risks such as distant metastasis and prostate cancer-specific mortality.²

FDA approves 3-month formulation of leuprolide mesylate for advanced prostate cancer

Date: August 28, 2025

Indication: Advanced prostate cancer

Summary: The FDA has approved a 3-month formulation of leuprolide mesylate (Camcevi ETM; 21 mg) for adults with advanced prostate cancer, Foresee Pharmaceuticals announced.³ A 6-month version was previously approved in 2021.⁴ Approval was based on a phase 3 trial (NCT03261999) in which 97.9% of patients maintained castrate-level testosterone suppression (≤50 ng/dL) from day 28 through day 168. At day 28, the suppression rate was 98.6%, with mean testosterone reduced to 17.8 ng/dL. The formulation was well tolerated; most adverse events were mild to moderate, with hot flushing, hypertension, weight gain, and injection site hemorrhage being the most common.³

FDA issues complete response letter for 89Zr-DFO-girentuximab in ccRCC

Date: August 28, 2025

Indication: PET imaging of clear cell renal cell carcinoma

Summary: The FDA has issued a complete response letter (CRL) for the biologics license application of 89Zr-DFO-girentuximab (Zircaix; TLX250-CDx), Telix’s investigational PET imaging agent for clear cell renal cell carcinoma. The CRL cites Chemistry, Manufacturing, and Controls deficiencies, including Form 483 notices for third-party manufacturing partners, and requests additional data to confirm comparability between trial and commercial-scale products. Telix said it plans immediate remediation and a Type A meeting with the FDA.⁵

FDA approves gemcitabine intravesical system for BCG-unresponsive NMIBC

Date: September 9, 2025

Indication: BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors

Summary: The FDA has approved gemcitabine intravesical system (Inlexzo; formerly TAR-200) for adults with BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. Inlexzo is the first intravesical drug delivery system to provide extended local therapy, releasing gemcitabine in the bladder for 3 weeks per cycle.⁶ Approval was based on data from the phase 2b SunRISe-1 trial (NCT04640623), in which Inlexzo achieved an 82% complete response rate, with 51% of patients maintaining response for at least 1 year.⁷

FDA approves pembrolizumab for subcutaneous injection for solid tumors

Date: September 19, 2025

Indication: Previously approved solid tumor indications of intravenous pembrolizumab in adult and pediatric patients (12 years or older)

Summary: The FDA has approved 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). Approval was based on the phase 3 MK-3475A-D77 trial (NCT05722015), where subcutaneous pembrolizumab showed noninferior pharmacokinetics and comparable efficacy to IV dosing in patients with metastatic non–small cell lung cancer. Response rates, progression-free survival, and overall survival were similar across arms, with safety profiles consistent. The subcutaneous option, administered in approximately 2 minutes, reduced patient chair and treatment room time by nearly 50% and significantly cut health care staff workload.⁹

REFERENCES

1. Philips advances minimally invasive therapy procedures in prostate cancer care with FDA 510(k) clearance for image-guided navigation technology. News release. Royal Philips. July 23, 2025. Accessed July 23, 2025. https://www.philips.com/a-w/about/news/archive/standard/news/press/2025/philips-advances-minimally-invasive-therapy-procedures-in-prostate-cancer-care-with-fda-510-k-clearance-for-image-guided-navigation-technology.html

2. Artera receives U.S. FDA De Novo Marketing Authorization for AI-digital pathology software revolutionizing prostate cancer care. News release. Artera. August 13, 2025. Accessed August 13, 2025. https://www.businesswire.com/news/home/20250813857439/en/Artera-Receives-U.S.-FDA-De-Novo-Marketing-Authorization-for-AI-Digital-Pathology-Software-Revolutionizing-Prostate-Cancer-Care

3. Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI ETM for the Treatment of Advanced Prostate Cancer. Foresee Pharmaceuticals. August 28, 2025. Accessed August 29, 2025. https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-fda-approval-of-camcevi-etm-for-the-treatment-of-advanced-prostate-cancer-302541714.html

4. Foresee Pharmaceuticals announces FDA approval of CAMCEVI for the treatment of advanced prostate cancer; Accord BioPharma to head the U.S. commercialization. News release. Foresee Pharmaceuticals. May 26, 2021. Accessed August 28, 2025. https://www.foreseepharma.com/en-us/news/1/340

5. Telix provides regulatory update on TLX250-CDx. News release. Telix Pharmaceuticals. August 28, 2025. Accessed August 28, 2025. https://ir.telixpharma.com/static-files/6264a633-04e6-4eb2-81c5-f9fc40d113d2

6. 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 September 9, 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

7. Daneshmand S, Heijden MSV, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: Results from the phase IIb SunRISe-1 study. J Clin Oncol. 2025:101200JCO2501651. doi:10.1200/JCO-25-01651

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

9. Merck’s investigational subcutaneous pembrolizumab with berahyaluronidase alfa demonstrates noninferior pharmacokinetics compared to intravenous (IV) KEYTRUDA (pembrolizumab) in pivotal 3475A-D77 trial. News release. Merck. March 27, 2025. Accessed September 19, 2025. https://www.businesswire.com/news/home/20250327895076/en/Mercks-Investigational-Subcutaneous-Pembrolizumab-With-Berahyaluronidase-Alfa-Demonstrates-Noninferior-Pharmacokinetics-Compared-to-Intravenous-IV-KEYTRUDA-pembrolizumab-in-Pivotal-3475A-D77-Trial