June 6th 2023
Findings from the phase 3 SWOG S1011 trial highlight no significant differences between extended lymphadenectomy vs standard lymphadenectomy in terms of disease-free survival in patients with muscle-invasive breast 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.
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.
Blood-Based Biomarkers May Predict Disease Response in Advanced Urothelial Carcinoma
September 11th 2022At ESMO 2022, peripheral blood samples taken from patients with advanced or metastatic urothelial carcinoma treated on the phase 3 JAVELIN Bladder 100 trial showed there may be a potential to predict disease response to avelumab.
Enfortumab Vedotin Plus Pembrolizumab Yield Promising Results in Advanced Urothelial Carcinoma
July 26th 2022Results from cohort K of the phase 1b/2 KEYNOTE-869 trial showed improved responses for patients with advanced or metastatic urothelial carcinoma when treated with enfortumab vedotin-efjv plus pembrolizumab.