Washington, October 15 The U.S. Food and Drug Administration has expanded the approval of Anktiva to include adults with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer, building on its prior authorization for patients with carcinoma in situ. This update allows the drug to be used in a broader group of patients who have not responded to standard Bacillus Calmette-Guérin therapy and whose tumors remain confined to the bladder lining.
The decision relies on evidence from the QUILT-3.032 trial, which evaluated Anktiva in combination with BCG in 77 patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer featuring carcinoma in situ, with or without papillary components. The FDA determined that the efficacy observed in this population supports extrapolation to patients with high-grade papillary-only disease, based on shared biological mechanisms and clinical behavior.
Anktiva functions as an interleukin-15 receptor agonist, combining nogapendekin alfa—a modified, more potent form of human IL-15—with inbakicept, an IL-15 receptor subunit alpha agonist. This fixed-dose combination is designed to stimulate immune pathways that help the body recognize and attack cancer cells when delivered directly into the bladder alongside BCG. For induction therapy, the regimen involves intravesical administration of 400 micrograms of Anktiva with BCG once weekly for six weeks.
If a complete response is not achieved at the three-month mark, a second induction course may be offered. Maintenance therapy consists of the same dose given with BCG once weekly for three weeks at months four, seven, ten, thirteen, and nineteen, with a maximum treatment duration of 37 months.
The drug received initial FDA approval in April 2024 for use with BCG in adults with BCG-unresponsive non-muscle invasive bladder cancer and carcinoma in situ, with or without papillary tumors. That approval followed the QUILT-3.032 study and was granted to Altor BioScience, an indirect wholly-owned subsidiary of ImmunityBio. Common side effects reported in clinical use include increased creatinine levels, dysuria, hematuria, urinary frequency, urgency, urinary tract infection, elevated potassium, musculoskeletal pain, chills, and fever.
These reactions are monitored closely during treatment to manage patient safety and comfort. Outside the United States, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion in December 2025, recommending conditional marketing authorization for Anktiva. The drug received full authorization in the European Union in February 2026 for the same indication, with Serum Life Science Europe as the applicant. Consult your doctor for medical advice.
