Urology Times 50 Innovations Series: BCG therapy for bladder cancer

The application is based on results from the phase 3 CheckMate-901 trial.

In this episode, Ashish M. Kamat, MD, MBBS, highlights the state of bladder cancer care in recognition of Bladder Cancer Awareness Month.

The FDA has accepted a resubmitted biologics license application for N-803 for use in combination with BCG for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.

“It's not a replacement for clinical judgment, obviously. But at the end of the day, the idea is that it shows you what your next steps are based on what the American Urological Association and [Society of Urologic Oncology] guidelines are for non-muscle invasive bladder cancer,” Chad R. Ritch, MD, MBA, FACS.

An approach combining chemotherapy and immunotherapy could help preserve quality of life.

"If additional research confirms our findings, this may lead to a new paradigm in the treatment of muscle-invasive bladder cancer," says Matthew Galsky, MD.