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Results from the KEYNOTE-905 trial led to the approval of pembrolizumab/enfortumab vedotin in muscle invasive bladder cancer.
FDA OKs Pembrolizumab/Enfortumab Vedotin in Muscle Invasive Bladder Cancer

November 21st 2025

Results from the KEYNOTE-905 trial led to the approval of pembrolizumab/enfortumab vedotin in muscle invasive bladder cancer.

Most patients with BCG-unresponsive NMIBC treated with detalimogene voraplasmid did not experience TRAEs, with only 1.6% experiencing dose interruptions.
Detalimogene Exhibits Improved Response Rate in BCG-Unresponsive NMIBC

November 12th 2025

The FDA agreed that data from the UTOPIA trial, with UGN-103 demonstrating a 77.8% 3-month CR rate in patients with LG-IR-NMIBC, support an NDA submission.
UGN-103 Exhibits Durable Responses in Recurrent LG-IR-NMIBC

November 6th 2025

BL-B01D1 Shows Preliminary Efficacy, Favorable Safety in Urothelial Cancer

November 1st 2025

Enfortumab vedotin plus pembrolizumab before and after surgery improved EFS vs surgery alone in patients with MIBC in the phase 3 EV-303 trial.
FDA Grants Priority Review to Enfortumab Vedotin Combo in MIBC Subset

October 22nd 2025

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