With the continuous advancement of scientific research, treatment strategies for urologic malignancies have evolved far beyond traditional chemotherapy. Targeted therapies, immunotherapy, and radioligand therapies are now reshaping the therapeutic landscape.To better support clinical practice, Oncology Frontier – Urology Stream has compiled a summary of new drugs approved in 2025 by the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for the treatment of urologic cancers, together with their approved indications. This overview is intended to provide clinicians with a concise and practical reference.
China Approvals (NMPA)
1. Prostate Cancer
Deutenzalutamide
Approval Date: May 27, 2025
Indication:
Approved for adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have experienced disease progression following treatment with abiraterone acetate and chemotherapy, and who have not previously received a next-generation androgen receptor inhibitor.
Lutetium-177–Labeled PSMA-Targeted Radioligand
Approval Date: November 4, 2025
Indications:
- Adult patients with prostate-specific membrane antigen (PSMA)-positive mCRPC who have progressed after prior androgen receptor pathway inhibitor (ARPI) therapy and taxane-based chemotherapy.
- Adult patients with PSMA-positive mCRPC who have progressed after ARPI therapy and are suitable candidates for delaying chemotherapy.
This approval further consolidates the role of PSMA-targeted radioligand therapy in advanced prostate cancer management.
2. Urothelial Carcinoma
Erdafitinib
Approval Date: January 8, 2025
Indication:
Approved for adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 genetic alterations, whose disease has progressed during or after at least one prior anti–PD-1/PD-L1 therapy, and who are not candidates for surgical resection.
This marks an important advancement in biomarker-driven precision treatment for urothelial carcinoma.
United States Approvals (FDA)
1. Prostate Cancer
Lutetium-177–Labeled PSMA-Targeted Radioligand
Approval Date: March 28, 2025
Indication:
Approved for adult patients with PSMA-positive mCRPC who have previously received ARPI therapy and are considered appropriate candidates for delaying taxane-based chemotherapy.
Darolutamide
Approval Date: June 3, 2025
Indication:
Approved for the treatment of metastatic castration-sensitive prostate cancer (mCSPC).
The FDA had previously approved darolutamide in combination with docetaxel for mCSPC; this updated approval further expands its therapeutic application.
Niraparib
Approval Date: December 12, 2025
Indication:
Approved in combination with abiraterone acetate and prednisone for adult patients with metastatic castration-sensitive prostate cancer harboring deleterious or suspected deleterious BRCA2 mutations, as identified by an FDA-approved test.
This approval extends PARP inhibitor–based precision therapy into earlier disease settings.
Rucaparib
Approval Date: December 17, 2025
Indication:
Approved for adult patients with deleterious BRCA mutations (germline and/or somatic) who have metastatic castration-resistant prostate cancer and have previously received androgen receptor–directed therapy.
2. Bladder Cancer
Durvalumab
Approval Date: March 28, 2025
Indication:
Approved in combination with gemcitabine and cisplatin as neoadjuvant therapy, followed by durvalumab monotherapy as adjuvant treatment after radical cystectomy, for adult patients with muscle-invasive bladder cancer (MIBC).
This approval reinforces the role of perioperative immunotherapy in bladder cancer management.
Mitomycin Intravesical Solution
Approval Date: June 12, 2025
Indication:
Approved for adult patients with recurrent, low-grade, intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC).
Gemcitabine Intravesical Drug Delivery System
Approval Date: September 9, 2025
Indication:
Approved for adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC), including carcinoma in situ (CIS) with or without papillary tumors.
Pembrolizumab (including subcutaneous formulation) + Enfortumab Vedotin
Approval Date: November 21, 2025
Indication:
Approved as neoadjuvant therapy prior to cystectomy and as adjuvant therapy following surgery in adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.
This combination expands the immunotherapy plus antibody-drug conjugate strategy into the perioperative setting.
Summary
In 2025, regulatory approvals in both China and the United States significantly enriched the therapeutic landscape for urologic cancers. Radioligand therapy, PARP inhibitors, immune checkpoint inhibitors, antibody-drug conjugates, and innovative intravesical drug delivery systems collectively reflect three major trends:
- Precision treatment guided by molecular profiling
- Expansion of perioperative systemic therapy
- Earlier integration of targeted and immunotherapy strategies
These advances provide clinicians with new evidence-based treatment options across disease stages and molecular subgroups, marking continued progress toward individualized and optimized care in urologic oncology.
Information summarized from official NMPA and FDA announcements. Any omissions or updates are welcome for further discussion.
