FDA APPROVES FIRST TREATMENT FOR CERTAIN PEOPLE WITH BCG-UNRESPONSIVE BLADDER CANCER

SILVER SPRING, Md., Oct. 14 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:

The U.S. Food and Drug Administration today expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guerin (BCG), to include adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG treatment. Anktiva is the first FDA-approved treatment specifically for patients with BCG-unresponsive, high-grade papillary-only disease.

The approval marks a new FDA approach to evaluating treatments for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The agency based its decision...