June 12th 2025
Data from the phase 3 ENVISION trial support the FDA approval of the mitomycin solution for patients with recurrent, low-grade, intermediate-risk NMIBC.
Enfortumab/Pembrolizumab Dosing Schedule ‘Groundbreaking’ in Urothelial Cancer
April 4th 2023Nazy Zomorodian, NP, spoke with CancerNetwork® about the unique dosing schedule of enfortumab vedotin plus pembrolizumab following its accelerated approval by the FDA in advanced/metastatic urothelial cancer.
Enfortumab Vedotin Combo Gets Accelerated FDA Nod for Urothelial Cancer
April 3rd 2023Results from cohort K of the phase 1b/2 KEYNOTE-869 trial led to the accelerated approval of enfortumab vedotin plus pembrolizumab in patients with locally advanced or metastatic urothelial cancer who cannot receive cisplatin-based chemotherapy.
Genomic Analysis Yields ‘Hypothesis Generating’ Data in Bladder Cancer Subtype
February 26th 2023An expert from Chase Comprehensive Cancer Center discusses how findings from a genomic analysis of the phase 2 BLASST-1 trial may identify biomarkers of response and resistance to nivolumab/chemotherapy in muscle-invasive bladder cancer.
Atezolizumab/Chemo Demonstrates Survival Trend in Urothelial Carcinoma
February 18th 2023Results from the phase 3 IMvigor130 trial reveal a trend towards overall survival improvement when atezolizumab plus chemotherapy was given to patients with locally advanced or metastatic urothelial carcinoma vs placebo.
Sacituzumab Govitecan Yields Consistent Benefit in Platinum-Ineligible mUC
February 18th 2023Data from the phase 2 TROPHY-U-01 trial support further evaluation of sacituzumab govitecan in patients with metastatic urothelial cancer following immune checkpoint inhibitor therapy, according to the lead investigator.
FDA Accepts sBLAs for Enfortumab Vedotin/Pembrolizumab in Advanced or Metastatic Urothelial Cancer
December 21st 2022The FDA has set the Prescription Drug User Fee Act date for April 21, 2023 for each supplemental biologics license application of enfortumab vedotin-ejfv and pembrolizumab in urothelial carcinoma.
FDA Approves First Gene Therapy for Non-Muscle Invasive Bladder Cancer
December 16th 2022Patients with high-risk Bacillus Calmette Guérin–unresponsive non-muscle invasive bladder cancer can now receive treatment with nadofaragene firadenovec-vncg—the first gene therapy—following its approval by the FDA.
Pembrolizumab Remains Effective for Years in a Bladder Cancer Subset
December 5th 2022Long-term follow-up showed that the use of pembrolizumab monotherapy maintained durable complete responses, while rates of upstaging at the time of radical cystectomy were consistent with previous findings in the KEYNOTE-057 trial in patients with a bladder cancer subset.