FDA Expands Anktiva Indication for Bladder Cancer
The U.S. Food and Drug Administration on October 14, 2026 approved an expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva), used with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
According to the FDA, the revised indication extends the earlier population — patients with carcinoma in situ (CIS) with or without papillary tumors — to also include patients with high-grade papillary-only tumors. Anktiva is made by Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
Full prescribing information will be posted on Drugs@FDA. NMIBC refers to bladder cancer that has not invaded the bladder muscle; disease that no longer responds to BCG therapy has limited treatment options.
(Source: U.S. Food and Drug Administration approval)
Source: U.S. Food and Drug Administration approval
Published by GSM · USA (original Chinese edition)
Photo: 图片：SozvezdieL 摄（CC BY 4.0），经 Wikimedia Commons，图为实验室场景
