FDA approves Anktiva,(N-803, or nogapendekin alfa inbakicept-pmln) first-in-class IL-15 receptor agonist for BCG-unresponsive non-muscle invasive bladder cancer

Anktiva, a first-in-class IL-15 agonist immunotherapy for NMIBC, received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR).

Bladder cancer is the 10th most commonly-diagnosed cancer globally, and in the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024. At the time of diagnosis, about 80% of cases are non-muscle invasive bladder cancer (NMIBC), wherein the cancer is found only on the inner layer of the bladder wall. The standard therapy for NMIBC is intravesical instillation (delivery to the bladder via a catheter) of bacillus Calmette-Guerin (BCG). BCG is a benign bacteria that induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients. In ~30-40% of patients, however, BCG will fail, and in ~50% that initially respond, cancer will recur.

“A new immunotherapy that builds upon our knowledge and experience with BCG as an immune stimulant is exciting to see,” said Ashish Kamat, M.D., MBBS, an Endowed Professor of Urologic Oncology and Cancer Research at University of Texas MD Anderson Cancer Center. “While patients have had limited options in the past after failure of BCG, nogapendekin alfa inbakicept-pmln, with its reported safety and efficacy, now offers them yet another choice in their quest to avoid a radical cystectomy. This is a big win for NMIBC patients everywhere.”

With the approval of Anktiva in combination with BCG, NMIBC patients who would otherwise face highly invasive surgery with life-long consequences have an important new therapeutic option with a long-term durable complete response.