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Genitourinary Cancers

FDA Approves Camcevi ETM, a 3-Month Formulation of Leuprolide Mesylate for Advanced Prostate Cancer

The FDA approved leuprolide mesylate 21 mg, a long-acting injectable formulation administered every three months (Camcevi ETM, Foresee Pharmaceuticals), as a treatment for advanced prostate cancer.

AUGUST 29, 2025

New Standard of Care for Metastatic Castration-Sensitive Prostate Cancer?

Adding niraparib (Zejula, GSK) to abiraterone acetate (Akeega, Janssen) plus prednisone (AAP) can help improve progression-free survival for people with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) gene alterations. 

JULY 23, 2025

Zusduri Approved for Recurrent Low-Grade Intermediate-Risk Non–Muscle-Invasive Bladder Cancer

The FDA has approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer.

JUNE 13, 2025

FDA Approves Nubeqa for Metastatic Castration-Sensitive Prostate Cancer

The FDA has approved darolutamide (Nubeqa, Bayer) for metastatic castration-sensitive prostate cancer (mCSPC). 

JUNE 3, 2025

Study Assesses Immune-Related AEs in Genitourinary Cancer Patients

Gastrointestinal immune-related adverse events (irAEs) are the most common AEs that lead to hospital admissions and readmissions in patients with genitourinary cancers prescribed immune checkpoint therapies.

MAY 28, 2025

Nivolumab Scores in Bladder and Renal Cancer Trials

Providing adjuvant nivolumab after radical resection continues to yield clinically meaningful disease-free survival for people with muscle-invasive bladder cancer.

APRIL 16, 2025

FDA Expands Pluvicto’s Metastatic Castration-Resistant Prostate Cancer Indication

The FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

APRIL 2, 2025

FDA Approves Imfinzi for Muscle-Invasive Bladder Cancer

The FDA has approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adults with muscle-invasive bladder cancer.

MARCH 31, 2025

Exercise Can Lessen Fatigue in Prostate Cancer Patients Undergoing ADT

Results from a new study demonstrate that a structured exercise program can decrease fatigue in patients with advanced prostate cancer undergoing ADT. 

MARCH 31, 2025

Early Survival Benefit Validates Addition of Radium-244 to Metastatic Prostate Cancer

In men with metastatic castration-resistant prostate cancer (mCRPC), the addition of Radium-233 (Ra233) (Xofigo, Bayer) to enzalutamide (Xtandi, Astellas Oncology/Pfizer Oncology) improves both radiological progression-free survival (rPFS) and overall survival (OS), according to an interim analysis of a multinational phase 3 trial. 

OCTOBER 30, 2024

Adding Checkpoint Inhibitor to Therapy Improves Overall Survival in Bladder Cancer

In patients with muscle-invasive bladder cancer (MIBC) eligible for neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy, the addition of an adjuvant durvalumab (Imfinzi, AstraZeneca) increases overall survival (OS), according to a phase 3 randomized trial. 

OCTOBER 16, 2024

Anktiva Approved for BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer

The FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

APRIL 24, 2024

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