Urothelial Cancer

Robert Huddart, PhD, discusses the FDA approval of erdafitinib for patients with FGFR3-altered metastatic urothelial carcinoma.

Chandler H. Park, MD, FACP, discusses the rationale for evaluating sacituzumab govitecan plus pembrolizumab in metastatic urothelial carcinoma.

Anthony T. Nguyen, MD, PhD, discusses the role of concurrent chemotherapy with trimodal therapy in patients with muscle-invasive bladder cancer.

Chandler H. Park, MD, FACP, discusses the use of sacituzumab govitecan plus pembrolizumab in patients with metastatic urothelial carcinoma.

Abhishek Tripathi, MD, discusses the phase 1/2 NEMIO trial of durvalumab/chemotherapy with/without tremelimumab in muscle-invasive bladder cancer.

The sNDA for enfortumab vedotin-ejfv plus pembrolizumab in patients with metastatic urothelial cancer has received priority review in Japan.

Anthony T. Nguyen, MD, PhD, discusses the methodology of trimodal therapy in patients with muscle-invasive bladder cancer.

Matthew Galsky, MD, discusses the significance of the FDA approval of enfortumab vedotin plus pembrolizumab as a first-line regimen in urothelial cancer.

Abhishek Tripathi, MD, discusses the significance of data from the phase 3 CheckMate 901 trial in metastatic or unresectable urothelial carcinoma.

Matthew Galsky, MD, discusses the FDA approval of enfortumab vedotin plus pembrolizumab in metastatic urothelial carcinoma.

Petros Grivas, MD, PhD, discusses 2023 updates regarding the treatment of patients with metastatic/unresectable urothelial carcinoma.

A sNDA seeking approval of enfortumab vedotin plus pembrolizumab for first-line use in patients with urothelial cancer has been submitted to Japan’s MHLW.

Dr. Sonpavde discusses the efficacy and safety findings from this randomized, open-label trial enrolling patients with advanced or metastatic urothelial carcinoma who had not received prior systemic chemotherapy.

The type II variation application for enfortumab vedotin plus pembrolizumab in untreated metastatic urothelial cancer has been validated by the EMA.

Adjuvant pembrolizumab generated a disease-free survival benefit vs observation in patients with muscle-invasive and locally advanced urothelial carcinoma.

Enfortumab vedotin plus pembrolizumab showed consistent overall survival and progression-free survival benefit in all patients enrolled in EV-302.

Pembrolizumab plus cabozantinib was efficacious in the first-line treatment of patients with cisplatin-ineligible urothelial carcinoma.

Andrea B. Apolo, MD, discusses the AMBASSADOR Alliance A031501 trial of adjuvant pembrolizumab in locally advanced/muscle-invasive urothelial carcinoma.

Assessment of urinary MRD status identified and enabled quantification of molecular responses with nadofaragene firadenovec in BCG-unresponsive NMIBC.

Amanda Nizam, MD, discusses findings from the UNITE study of enfortumab vedotin after maintenance avelumab in patients with advanced urothelial carcinoma.

As the treatment paradigm in urothelial cancer expands to include agents directed at various targets, NECTIN-4 has emerged as a promising treatment target.

Petros Grivas, MD, PhD, spotlights key advancements and research in urothelial cancer reported at the 2023 ESMO Congress, detailing findings from the phase 3 CheckMate 901, EV-302/KEYNOTE-A39, and THOR trials.

The FDA has approved erdafitinib (Balversa) for select adult patients with locally advanced or metastatic urothelial carcinoma harboring FGFR3 alterations.

Treatment with TLD-1433 led to 6-, 12-, and 15-month CR rates of 54%, 38%, and 37%, respectively, in patients with non–muscle invasive bladder cancer.

Thomas Powles, MD, MBBS, MRCP, discusses the use of enfortumab vedotin plus pembrolizumab in urothelial carcinoma based on data from the KEYNOTE-A39 trial.

Petros Grivas, MD, PhD, discusses outcomes associated with the phase 3 CheckMate 901 trial in metastatic or unresectable urothelial carcinoma.

The FDA has granted breakthrough therapy designation to TAR-200 for use in the treatment of patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle invasive bladder cancer who are not candidates for or opted not to receive radical cystectomy.

Andrea Necchi, MD, discusses results from the phase 2b SunRISe-1 trial of TAR-200 in patients with Bacillus Calmette-Guérin (BCG)–unresponsive, high-risk, non–muscle-invasive bladder cancer.

The FDA has granted fast track and breakthrough therapy designations to cretostimogene grenadenorepvec for use as a potential therapeutic option in patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.

In case you missed it, below are some of the drugs that were approved by the FDA in the month of December.