The FDA has approved a first-in-class bladder cancer drug.
Anktiva (interleukin (IL)-15 superagonist nogapendekin alfa inbakicept-pmln) administered with bacillus Calmette-Guérin was approved for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors, according to an April 22 FDA news release.
The drug study found 62% of patients had a complete response; 58% of those with a complete response had a duration of response lasting at least 12 months, and 40% had a duration lasting 24 months or longer.
Previously, the FDA declined approval because of deficiencies the agency observed during its prelicense inspection of third-party manufacturing organizations. In October 2023, ImmunityBio, the company that makes Anktiva, resubmitted its license and it was accepted.