May 10th 2024
Phase 2 data support the potential of replacing cisplatin with nab-paclitaxel as a backbone therapy for those with muscle-invasive bladder cancer.
May 8th 2024
Findings from the CheckMate-901 study support the use of frontline nivolumab plus gemcitabine/cisplatin in advanced urothelial carcinoma.
May 7th 2024
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.
May 4th 2024
Treatment with cretostimogene grenadenorepvec appears tolerable among patients with high-risk BCG–unresponsive NMIBC in the phase 3 BOND-003 trial.
April 28th 2024
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.
Pembrolizumab Improves DFS Vs Observation in Muscle-Invasive Urothelial Carcinoma
Interim findings from a phase 3 trial support adjuvant pembrolizumab as a new therapeutic option for those with muscle-invasive urothelial carcinoma at high risk of recurrence.
Pembrolizumab Combo Yields Efficacy in Advanced Urothelial Carcinoma
Combining pembrolizumab with cabozantinib produces encouraging efficacy in platinum-ineligible patients with advanced urothelial carcinoma, says Rohit K. Jain, MD, MPH.
Enfortumab Vedotin Combo Improves Outcomes in Urothelial Cancer Subgroups
Benefits with enfortumab vedotin plus pembrolizumab in prespecified patient subgroups with urothelial carcinoma in the EV-302 trial appear to be consistent with outcomes in the overall study population.
Updated AUA/SUO Guidelines May Improve NMIBC Evaluation and Management
Clinical practice guideline amendments detail novel urinary biomarkers and agents that may improve Bacillus Calmette-Guerin efficacy in the management of non-muscle invasive bladder cancer.
Nadofaragene Firadenovec Results in uMRD-Negative Status in NMBIC
uMRD-negative status linked to recurrence-free outcomes with nadofaragene firadenovec in NMIBC
EMA Accepts Review for Enfortumab Vedotin Combo in Urothelial Cancer
Supporting data for the EMA comes from the phase 3 EV-302 trial, which assessed the efficacy of enfortumab vedotin in combination with pembrolizumab compared with chemotherapy.
Erdafitinib Approved by FDA in Metastatic Urothelial Carcinoma
Patients with metastatic urothelial carcinoma who are susceptible to FGFR3 gene alterations may now receive erdafitinib, according to the FDA.
Dose-Dense MVAC Yields No OS Benefit for Muscle-Invasive Bladder Cancer
Investigators note that the phase 3 VESPER study’s data support the use of 6 neoadjuvant cycles of dose-dense MVAC vs 4 in muscle-invasive bladder cancer.
Atezolizumab May Yield OS Benefit in PD-L1+ Advanced Urothelial Carcinoma
Treatment with atezolizumab monotherapy yields an acceptable toxicity profile compared with chemotherapy among those with advanced or metastatic urothelial carcinoma.
Enfortumab Vedotin Combo Is Approved by FDA for Advanced Urothelial Cancer
Patients with locally advanced or metastatic urothelial cancer may now receive enfortumab vedotin plus pembrolizumab following its approval by the FDA.
Frontline Nivolumab/Chemo Earns FDA Priority Review in Urothelial Carcinoma
The FDA has set a Prescription Drug User Fee Act date of April 5, 2024 for nivolumab plus chemotherapy in unresectable or metastatic urothelial carcinoma.
UGN-102 Yields Complete Responses in Non-Muscle Invasive Bladder Cancer
If approved, UGN-102 may become the first non-surgical option for patients with low-grade intermediate-risk non–muscle invasive bladder cancer, says Sandip Prasad, MD.
Nadofaragene Firadenovec Produces Enduring Clinical Activity in NMIBC
Data from the phase 3 CS-003 study underscore the importance of long-term follow-up findings with novel therapies for high-grade non–muscle-invasive bladder cancer, says Stephen A. Boorjian MD.
Chemo/Nephroureterectomy Increases pCR Likelihood in Urothelial Carcinoma
Patients receiving neoadjuvant chemotherapy plus radical nephroureterectomy for upper tract urothelial carcinoma appear more likely to experience nodal downstaging.
Cretostimogene Grenadenorepvec Yields Durable Responses in NMIBC
More than half of the patients with non–muscle-invasive bladder cancer in the BOND-003 trial achieve a complete response at 6 months following treatment with cretostimogene grenadenorepvec.
Enfortumab Vedotin Shows Meaningful, Sustained OS Benefit in Bladder Cancer
Data from the phase 3 EV-301 study turn up no new safety signals in patients with advanced urothelial carcinoma treated with enfortumab vedotin.
Durvalumab Combo Offers OS/EFS Benefit in Muscle-Invasive Urothelial Carcinoma
More than half of resected patients with muscle-invasive urothelial carcinoma achieve a pathologic response with durvalumab plus neoadjuvant cisplatin/gemcitabine in the phase 2 SAKK 06/17 trial.
FDA Accepts Resubmitted BLA for N-803 Plus BCG in NMIBC
The regulatory agency has set a Prescription Drug User Fee Act date of April 23, 2024 for N-803 plus BCG as a treatment for BCG-unresponsive, non–muscle invasive bladder carcinoma.
TAR-200 Yields Complete Responses in BCG-Unresponsive High-Risk NMIBC
Efficacy and safety data from the phase 2b SUNRISE-1 trial support the ongoing evaluations of TAR-200 as a treatment for patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer.
Enfortumab Vedotin Combo Boosts Survival Vs Chemo in Urothelial Carcinoma
Data from the phase 3 EV-302 trial support enfortumab vedotin plus pembrolizumab as a potential standard of care in locally advanced or metastatic urothelial carcinoma.
Nivolumab/Chemo Yields Survival Benefits in Metastatic Urothelial Carcinoma
Treatment with nivolumab plus gemcitabine-cisplatin appears to confer rapid and enduring responses in patients with unresectable or metastatic urothelial carcinoma in the phase 3 CheckMate 901 trial.
Don’t Be Afraid to Ask Questions Along the Bladder Cancer Journey, Patients and Clinicians Advise
A patient with bladder cancer recounts his diagnosis while Rohit Jain, MD, and Anand B. Shah, PharmD, BCOP, review treatment options and the toxicity associated with them.
Pembrolizumab Yields Meaningful DFS in Muscle-Invasive Urothelial Carcinoma
Investigators will continue to assess overall survival in patients treated with pembrolizumab for localized muscle-invasive urothelial carcinoma as part of the phase 3 AMBASSADOR trial.