The FDA on October 14, 2026, expanded the approval of Anktiva (nogapendekin alfa inbakicept-pmln), given with BCG, to include adults with high-grade, papillary-only non-muscle-invasive bladder cancer that no longer responds to BCG, according to an FDA notice on the expanded indication. The drug was previously approved only for patients whose disease included carcinoma in situ, a flat form of the cancer, with or without papillary tumors.
ImmunityBio, the drug's maker, said in a company announcement filed with the SEC that this is the first FDA approval to include patients with papillary-only tumors in this setting. Citing published research, the company said papillary disease accounts for about 85% of people with non-muscle-invasive bladder cancer.
