GENITOURINARY CANCERS

Dr Stein reviews PEACE-3 data supporting radium-223 plus enzalutamide in mCRPC and the role of bone-protecting agents in this setting.

Interim data from the LEGEND pivotal cohort show detalimogene achieved complete responses in more than half of patients with BCG-unresponsive non-muscle invasive bladder cancer.

S-HIFU achieved 71% ADT-free survival at 30 months in recurrent prostate cancer post-radiation, with better outcomes in patients with lower PSA and Gleason scores.

The FDA's Oncologic Drugs Advisory Committee voted in favor 7 to 1 that benefits of capivasertib outweighed risks.

Mark Stein, MD, explores managing mHSPC through PSMA PET imaging, tumor burden assessment, and AMPLITUDE trial data while considering clinical context.

Phase 1 trial of JANX014, a PSMA-targeted T-cell engager, begins in mCRPC, building on prior safety data to expand treatment strategies.

The FDA has granted a priority review to the supplemental biologics license application for enfortumab vedotin/pembrolizumab to all patients with MIBC regardless of cisplatin eligibility.

The first patient has been dosed in a phase 1 trial (NCT05997615) of VIR-5500, a dual-masked PSMA-targeting T-cell engager for metastatic prostate cancer.

The FDA has granted fast track and rolling review status to Celltrion’s CT-P71, a Nectin-4 targeting ADC for treating advanced urothelial carcinoma.

CMS has issued a permanent billing and reimbursement J-code, J9183, for the gemcitabine intravesical system (Inlexzo) in NMIBC.

Transdermal estradiol offers fewer hot flashes and lower fracture rates, but higher rates of gynecomastia, as it meets the noninferiority bar against LHRH agonists.

A wave of innovations across antibody-drug conjugates, synergistic combinations, and expanding biomarkers is transforming the genitourinary cancer landscape from metastatic rescue toward curative, earlier-line paradigms.

The FDA approved a label change for nadofaragene firadenovec-vncg (Adstiladrin) in non–muscle-invasive bladder cancer to improve preparation time.

Nadofaragene firadenovec-vncg (Adstiladrin) received an expanded NCCN recommendation for patients with BCG-unresponsive NMIBC.

Early results from TALAPRO-3 suggest that the combination of talazoparib and enzalutamide may redefine the treatment paradigm for HRR gene-mutated mCSPC, demonstrating that targeting DNA damage repair earlier in the disease course substantially delays radiographic progression.

The combination of nogapendekin alfa inbakicept-pmln (Anktiva) and Bacillus Calmette-Guérin was added to the NCCN clinical guidelines for bladder cancer, according to the manufacturer.

Sacituzumab govitecan plus pembrolizumab may enable bladder preservation in MIBC.

A supplemental Biologics License Application has been submitted for nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors.

The FDA approves a new formulation of piflufolastat F 18, enhancing prostate cancer imaging with improved efficiency and patient access.

AKY-1189 gains fast track designation in urothelial cancer.

CAPItello-281 shows capivasertib plus abiraterone extends rPFS in PTEN-deficient mHSPC with manageable toxicity and preserved overall quality of life.

Short-course enzalutamide in recurrent prostate cancer slashes PSA, but PSMA-PET tumor volume misleads, raising overtreatment concerns.

PEACE-2 finds adding cabazitaxel to ADT plus radiotherapy fails to improve survival in high-risk localized prostate cancer, while increasing severe toxicities and deaths.

Findings from the phase 3 LITESPARK-011 trial favored belzutifan/lenvatinib vs cabozantinib in PFS and ORR.