January 18th 2025
UGN-102 elicited complete responses in 79.6% of patients with non–muscle-invasive bladder cancer at 3 months in the ENVISION trial.
January 15th 2025
Data from the phase 2b SunRISe-1 study support the NDA for TAR-200 in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer with CIS.
January 11th 2025
The approved combination of enfortumab vedotin and pembrolizumab provides an alternative to chemotherapy for patients in China.
December 6th 2024
The FDA set a Prescription Drug User Fee act date in the second quarter of 2025 for durvalumab plus chemotherapy in muscle-invasive bladder cancer.
Discerning the Best Frontline, Personalized Treatment in Urothelial Carcinoma
“How do we personalize and improve patient selection for frontline treatment now that patients are living, on average, more than 2 years with this aggressive cancer?” said David H. Aggen, MD, PhD
Pembrolizumab/Cisplatin Combo Shows Promise in Small Cell Bladder Cancer, Neuroendocrine Prostate Cancer
Pembrolizumab with platinum-based chemotherapy yielded encouraging progression-free and overall survival outcomes in this patient population.
Extended Lymphadenectomy Does Not Improve DFS/OS in Bladder Cancer
Disease-free survival and overall survival were lower with extended lymphadenectomy compared with standard lymphadenectomy.
Gilead Sciences to Withdraw Sacituzumab Govitecan Bladder Cancer Approval Status
Data from TROPiCS-04 did not meet the primary end point of overall survival among those with locally advanced or metastatic urothelial cancer.
FDA Accepts New Drug Application for UGN-102 for Bladder Cancer
The decision is backed by robust efficacy data from the phase 3 ENVISION trial, evaluating UGN-102 in patients with non-muscle invasive bladder cancer.
TAR-200 Study in Muscle-Invasive Bladder Cancer Discontinued
TAR-200 plus cetrelimab did not yield significant results vs chemoradiation in muscle-invasive bladder cancer.
Enfortumab Vedotin Combo Earns Japanese Approval for Urothelial Carcinoma
Phase 3 EV-302 results supported the approval, showing a statically significant survival benefit compared with chemotherapy in urothelial carcinoma.
Neoadjuvant TAR-200 Combo Shows Responses in Muscle-Invasive Bladder Cancer
Data from the SunRISe-4 trial demonstrate the benefit of adding TAR-200 to checkpoint inhibition among patients with muscle-invasive bladder cancer.
Neoadjuvant Durvalumab/Chemo, Adjuvant Durvalumab Improves EFS in Cisplatin-Eligible MIBC
Thomas Powles, MBBS, MRCP, MD, presented results from the NIAGRA trial assessing perioperative durvalumab in patients with cisplatin-eligible MIBC.
Durvalumab Shows Improvement in EFS/OS for Muscle-Invasive Bladder Cancer
Durvalumab improved efficacy in patients with muscle-invasive bladder cancer.
UGN-102 Shows Durable 1-Year Responses in Low-Grade, Intermediate-Risk NMIBC
UGN-102 also demonstrated a 79.6% complete response rate at 3 months in the phase 3 ENVISION trial.
EV-302 PRO Outcomes Find Consistent Efficacy Data in Urothelial Carcinoma
Patient-reported outcomes from the EV-302 trial found consistent efficacy and safety outcomes for patients with urothelial carcinoma.
Sacituzumab Govitecan Produces Finite Efficacy After Enfortumab Vedotin in Bladder Cancer Subsect
Limited efficacy was observed when sacituzumab govitecan was given after enfortumab vedodin in metastatic urothelial carcinoma.
Sacituzumab Govitecan Yields Response But Questions Remain on Usefulness in Bladder Cancer
Adjuvant sacituzumab govitecan demonstrated a complete response, but its future in bladder cancer is uncertain after a recent protocol amendment.
Avelumab Plus Chemo Improved Survival in Muscle-Invasive Urothelial Carcinoma
Neoadjuvant avelumab plus cisplatin yielded high event-free survival in muscle-invasive urothelial carcinoma.
Nivolumab Combo Receives European Approval in Advanced Urothelial Carcinoma
The CheckMate -901 trial led to the approval of the nivolumab combination for unresectable or metastatic urothelial carcinoma in the European Union.
Nivolumab/Ipilimumab Shows Improved Benefit in Urothelial Carcinoma
Nivolumab plus ipilimumab has shown a response benefit when given at an increased dose for those with metastatic urothelial carcinoma.
Expert Commentary on the Product Profile of Enfortumab Vedotin Plus Pembrolizumab
Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC, gives his perspective on the approval of enfortumab vedotin plus pembrolizumab for patients with urothelial carcinoma.
Nivolumab Combo Shows Efficacy, Safety in Muscle-Invasive Bladder Cancer
Phase 2 data support the potential of replacing cisplatin with nab-paclitaxel as a backbone therapy for those with muscle-invasive bladder cancer.
Nivolumab Combo Significantly Boosts Survival in Urothelial Carcinoma
Findings from the CheckMate-901 study support the use of frontline nivolumab plus gemcitabine/cisplatin in advanced urothelial carcinoma.
Lasting Responses Observed With TAR-200 in BCG-Unresponsive NMIBC
All patients with a response to TAR-200 did not have progression to muscle-invasive bladder cancer or metastatic disease in the SunRISe-1 trial.
Novel Oncolytic Immunotherapy Yields Enduring Responses in High-Risk NMIBC
Treatment with cretostimogene grenadenorepvec appears tolerable among patients with high-risk BCG–unresponsive NMIBC in the phase 3 BOND-003 trial.
EU’s CHMP Recommends Nivolumab Combo Approval in Urothelial Carcinoma
Findings from the CheckMate-901 trial support the CHMP’s positive opinion of nivolumab plus chemotherapy in metastatic urothelial carcinoma.
FDA Approves Nogapendekin Alfa-inbakicept/BCG in BCG-unresponsive NMIBC
Nogapendekin alfa-inbakicept is now approved for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer.
MRD Negativity Status Following Surgery Confers Survival in MIBC
Patients with muscle-invasive bladder cancer who remain molecular residual disease negative following cystectomy may be spared from adjuvant therapy.
Enfortumab Vedotin Combo Yields Significant Survival in Urothelial Cancer
Enfortumab vedotin plus pembrolizumab appears to reduce the risk of disease progression or death vs chemotherapy in locally advanced or metastatic urothelial carcinoma.
Enfortumab Vedotin Combo Earns Priority Review in China for Bladder Cancer
Data from the phase 3 EV-302 trial support an application for enfortumab vedotin plus pembrolizumab as a treatment for patients with advanced bladder cancer in China.
FDA Approves First-line Nivolumab Combo for Urothelial Carcinoma
Results from the phase 3 CHECKMATE-901 trial led to the approval of nivolumab plus cisplatin and gemcitabine for patients with unresectable or metastatic urothelial carcinoma.
Enfortumab Vedotin Combo Earns Priority Review in Japan for Bladder Cancer
Data from the phase 3 EV-302 trial support the supplemental biologics license application for enfortumab vedotin plus pembrolizumab for patients with advanced or metastatic urothelial cancer in Japan.
Sacituzumab Govitecan Combo Shows Encouraging Responses in Bladder Cancer
Investigators report clinical benefit with sacituzumab govitecan plus pembrolizumab across all prespecified patient subgroups with metastatic urothelial cancer in cohort 3 of the phase 2 TROPHY-U-01 trial.