Latest Updates in Genitourinary Oncology

IL-15 Receptor Lymphocyte–Stimulating Agent NAI + BCG in BCG-Unresponsive Papillary-Only NMIBC

ANKTIVA® Plus BCG Demonstrates Durable Response, Bladder Preservation, and 96% Survival in BCG-Unresponsive Papillary NMIBC

This article reviews long-term outcomes of the IL-15 receptor agonist nogapendekin alfa inbakicept (NAI) combined with intravesical bacillus Calmette-Guérin (BCG)...
A New Era in MIBC: Perioperative Pembrolizumab + Enfortumab Vedotin Approved for Cisplatin-Ineligible Patients

A New Era in MIBC: Perioperative Pembrolizumab + Enfortumab Vedotin Approved for Cisplatin-Ineligible Patients

On November 21, 2025, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda or Keytruda Qlex) combined with enfortumab vedotin-ejfv...

Prospective DRIVE Study Demonstrates Strong Diagnostic Performance of CxBladder Triage Plus in Hematuria Evaluation

The CxBladder Triage Plus DRIVE study showed high accuracy in detecting urothelial carcinoma in patients with hematuria, with 94% sensitivity...

New CMS J-Code Set to Enhance Adoption of Mitomycin Therapy for Recurrent LG-IR-NMIBC

CMS has assigned a permanent J-code (J9282) to ZUSDURI, an intravesical mitomycin therapy for recurrent low-grade, intermediate-risk NMIBC, effective January...

IMvigor011: Signatera™ ctDNA Testing Guides Adjuvant Atezolizumab Benefit in Muscle-Invasive Bladder Cancer

Signatera-positive patients treated with atezolizumab had statistically significant improvements in disease-free and overall survival.

KEYNOTE-905: First Perioperative Therapy to Demonstrate Survival Benefit in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

First positive Phase 3 trial shows perioperative immunotherapy combination addresses critical gap for cisplatin-ineligible patients.

Latest in Renal Cell Carcinoma

FDA Issues CRL for Telix’s Breakthrough Kidney Cancer Imaging Agent TLX250-CDx Over Manufacturing Concerns

The FDA has issued a Complete Response Letter for TLX250-CDx (Zircaix), rejecting the biologics license application for this breakthrough therapy-designated...

The Effect of GLP-1 Receptor Agonists on Outcomes in Metastatic Renal Cell Carcinoma Patients Undergoing Immune Checkpoint Inhibitor Therapy

GLP-1 agonists in mRCC patients showed 51% lower mortality and reduced immune toxicity with checkpoint inhibitors in 994-patient analysis.

68Ga-NY104 PET/CT Outperforms 18F-FDG PET/CT in Metastatic ccRCC

68Ga-NY104 PET/CT shows better diagnostic efficacy than 18F-FDG PET/CT in patients with metastatic clear cell renal cell carcinoma.

Latest in Bladder Cancer

IMvigor011: Signatera™ ctDNA Testing Guides Adjuvant Atezolizumab Benefit in Muscle-Invasive Bladder Cancer

Signatera-positive patients treated with atezolizumab had statistically significant improvements in disease-free and overall survival.

KEYNOTE-905: First Perioperative Therapy to Demonstrate Survival Benefit in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

First positive Phase 3 trial shows perioperative immunotherapy combination addresses critical gap for cisplatin-ineligible patients.

Sasanlimab-BCG Combination Achieves 32% Risk Reduction in BCG-Naïve High-Risk NMIBC: Phase 3 CREST Trial Results

32% risk reduction in high-risk bladder cancer with sasanlimab-BCG combo—first treatment advance in 30+ years for BCG-naïve NMIBC patients.

FDA Approves Gemcitabine Intravesical System (Inlexzo) for BCG-Unresponsive Bladder Cancer

FDA approves gemcitabine intravesical system for BCG-unresponsive bladder cancer, showing 82% complete response rate in SunRISe-1 trial.

Ideaya Advances Precision Oncology Pipeline with Positive Data from Three Cancer Drug Candidates

Ideaya presents promising data across three cancer drugs: darovasertib (76% response), IDE849 (58% response), and IDE397 combo (57% response).

TAR-200 Achieves 82% Complete Response in BCG-Refractory Bladder Cancer: SunRISe-1 Results

New drug-releasing system, TAR-200, eliminated tumors in 82% of patients in phase 2 clinical trial for high-risk bladder cancer.

Latest in Urothelial Carcinoma

IL-15 Receptor Lymphocyte–Stimulating Agent NAI + BCG in BCG-Unresponsive Papillary-Only NMIBC

ANKTIVA® Plus BCG Demonstrates Durable Response, Bladder Preservation, and 96% Survival in BCG-Unresponsive Papillary NMIBC

This article reviews long-term outcomes of the IL-15 receptor agonist nogapendekin alfa inbakicept (NAI) combined with intravesical bacillus Calmette-Guérin (BCG)...
A New Era in MIBC: Perioperative Pembrolizumab + Enfortumab Vedotin Approved for Cisplatin-Ineligible Patients

A New Era in MIBC: Perioperative Pembrolizumab + Enfortumab Vedotin Approved for Cisplatin-Ineligible Patients

On November 21, 2025, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda or Keytruda Qlex) combined with enfortumab vedotin-ejfv...

Prospective DRIVE Study Demonstrates Strong Diagnostic Performance of CxBladder Triage Plus in Hematuria Evaluation

The CxBladder Triage Plus DRIVE study showed high accuracy in detecting urothelial carcinoma in patients with hematuria, with 94% sensitivity...

New CMS J-Code Set to Enhance Adoption of Mitomycin Therapy for Recurrent LG-IR-NMIBC

CMS has assigned a permanent J-code (J9282) to ZUSDURI, an intravesical mitomycin therapy for recurrent low-grade, intermediate-risk NMIBC, effective January...

IMvigor011: Signatera™ ctDNA Testing Guides Adjuvant Atezolizumab Benefit in Muscle-Invasive Bladder Cancer

Signatera-positive patients treated with atezolizumab had statistically significant improvements in disease-free and overall survival.

KEYNOTE-905: First Perioperative Therapy to Demonstrate Survival Benefit in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

First positive Phase 3 trial shows perioperative immunotherapy combination addresses critical gap for cisplatin-ineligible patients.

Latest in Prostate Cancer

Genomic Risk Classifiers in Prostate Cancer: Precise Tools Awaiting Clinical Standardization

GRCs for prostate cancer show promise but lack standardization, with usage patterns varying by income and geography in clinical practice.

Decipher Test Identifies Prostate Cancer Patients Who Benefit Most from Chemotherapy

Molecular profiling identifies prostate cancer patients who benefit most from chemotherapy, sparing others from unnecessary side effects.

FDA Expands Pluvicto Indication as PARP Inhibitors Advance Biomarker-Driven Prostate Cancer Strategies

FDA expands Pluvicto for earlier use while PARP inhibitors show benefit in BRCA1/2+ patients, advancing precision prostate cancer care.

FDA Grants De Novo Authorization to ArteraAI Prostate: First AI Tool for Prostate Cancer Prognosis

FDA grants de novo authorization to ArteraAI Prostate, first AI tool to prognosticate long-term outcomes in localized prostate cancer.

FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

FDA approves darolutamide (Nubeqa) for mCSPC: 46% reduction in disease progression risk vs placebo in ARANOTE trial.