Urothelial Cancer

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The FDA approved subcutaneous pembrolizumab for use in adult and pediatric solid tumor indications approved for intravenous pembrolizumab.

A new drug application for nadofaragene firadenovec in BCG-unresponsive bladder cancer has been accepted for review in Japan.

IDE397 plus sacituzumab govitecan shows preliminary efficacy in MTAP-deletion urothelial cancer.

The top 5 OncLive TV videos of the week cover insights in lung cancer, non–muscle-invasive bladder cancer, and colorectal cancer.

The FDA has approved TAR-200 in urothelial cancer and selumetinib in pediatric NF-1–associated inoperable plexiform neurofibromas, and more.

Joseph Jacob, MD, MCR, discusses the FDA approval of the gemcitabine intravesical system for patients with BCG-unresponsive NMIBC with carcinoma in situ.

Andrea Necchi, MD, discusses the design of the SURE-02 study evaluating pembrolizumab plus sacituzumab govitecan in muscle-invasive bladder cancer.

The FDA approved TAR-200 in patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors.

John P. Sfakianos, MD, discusses the rationale for evaluating mitomycin intravesical solution in recurrent, low-grade, intermediate-risk NMIBC.

The first part of a PMA seeking the approval of PredicineCARE as a companion diagnostic in bladder cancer was submitted to the FDA.

Waddah Arafat, MD, discusses ​how the use of neoadjuvant chemotherapy in MIBC has changed relative to the addition of immunotherapy to this paradigm.

Andrea Necchi, MD, discusses how initial findings from the SURE-02 study indicate the potential for bladder preservation over cystectomy in MIBC.

Andrea Necchi, MD, discusses biomarker data with perioperative sacituzumab govitecan plus pembrolizumab in cisplatin-ineligible MIBC.

Neoadjuvant sacituzumab govitecan plus pembrolizumab with adjuvant/maintenance pembrolizumab led to high cCR rates in MIBC.

William C. Huang, MD, discusses the FDA approval of UGN-102 for the treatment of patients with recurrent, low-grade, intermediate-risk NMIBC.

Jens Bedke, MD, discusses considerations for using enfortumab vedotin plus pembrolizumab in the frontline setting for advanced urothelial carcinoma.

Adjuvant atezolizumab boosts survival in bladder cancer, FDA clears companion diagnostic for nivolumab doublet in MSI-H/dMMR colorectal cancer, and more.

Alberto Martini, MD, discusses the safety of intravesical therapies in NMIBC, the efficacy of EG-70, and future trial needs in this population.

Alberto Martini, MD discusses how systemic treatment approaches and key trials have refined care for patients with BCG-unresponsive NMIBC.

Alpha1H met all primary and secondary end points in a phase 2 study in non–muscle-invasive bladder cancer.

Thomas Powles, MBBS, MRCP, MD, discusses how future clinical trials could leverage the CREST trial as a basis for BCG-naive NMIBC treatment development.

Alberto Martini, MD, discusses the current optimal role of nadofaragene firadenovec in the BCG-unresponsive NMIBC treatment paradigm.

Thomas Powles, MD, MBBS, MRCP, discusses challenges in identifying a predictive biomarker of response for sasanlimab in high-risk, BCG-naive NMIBC.

Jue Wang, MD, discusses the challenge of treatment discontinuation in older patients with metastatic castration-resistant prostate cancer.