The U.S. Food and Drug Administration (FDA) has approved the immunotherapy-boosting drug N-803, which is marketed under the brand name Anktiva, to be used in combination with the immunotherapy Bacillus Calmette-Guerin (BCG) for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer.
The decision was based on results of the QUILT 3.032 clinical trial, which was led by Dr. Karim Chamie, associate professor urology at the David Geffen School of Medicine at UCLA and a researcher at the UCLA Health Jonsson Comprehensive Cancer Center.
Findings from the phase 2/3 trial were presented at the 2022 American Society of Clinical Oncology annual meeting and published in NEJM Evidence. Chamie, who was the principal investigator for the trial, reported that this combination treatment resulted in longer overall survival and was more effective and safer than other treatments available for BCG-unresponsive non–muscle-invasive bladder cancer.
https://meetings.asco.org/abstracts-presentations/209231
https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200167
