Silver Spring, October 16 — On October 14, 2026, the U.S. Food and Drug Administration approved an expanded use of nogapendekin alfa inbakicept-pmln, marketed as Anktiva, in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer who have high-grade papillary-only tumors. This decision builds on the FDA’s original approval from April 2024 for the same regimen in patients with carcinoma in situ (CIS), with or without papillary tumors.
The updated indication now specifically includes those whose disease is limited to high-grade papillary disease, a group that previously had few effective bladder-sparing treatment options. The approval is grounded in data from the phase 2/3 QUILT-3.032 trial (NCT03022825), focusing on Cohort A, which enrolled 77 patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer featuring CIS with or without Ta/T1 papillary disease following transurethral resection.
In this cohort, the complete response rate, determined by cystoscopy, urine cytology, and biopsy, was 62 percent, with a 95 percent confidence interval ranging from 51 percent to 73 percent. Among those who achieved a complete response, 58 percent maintained that response for 12 months or longer, and 40 percent remained free of high-grade disease for 24 months or more.
The FDA concluded that sufficient clinical and non-clinical similarities exist between high-grade papillary tumors and carcinoma in situ to justify extrapolating efficacy from the CIS population to patients with high-grade papillary-only disease. The recommended dosing regimen begins with an induction phase: nogapendekin alfa inbakicept administered at 400 mcg intravesically with BCG once weekly for six weeks.
If residual CIS and/or high-grade Ta tumor is detected at month 3, a second induction course may be given. Maintenance therapy follows induction, with doses of 400 mcg intravesically with BCG delivered once weekly for three weeks at months 4, 7, 10, 13, and 19, totaling 15 doses. For patients with no evidence of high-grade disease at month 25 or later, maintenance may continue with BCG plus nogapendekin alfa inbakicept once weekly for three weeks at months 25, 31, and 37, allowing up to nine additional instillations.
The most frequently reported adverse effects were laboratory abnormalities, including increased creatinine, dysuria, hematuria, urinary frequency, and micturition urgency. The FDA’s decision was announced in an official news release dated October 14, 2026, and accessed the same day via https://tinyurl.com/38cp583x. No specific financial figures, pricing, or cost-effectiveness data were included in the source material supporting this approval. Consult your doctor for medical advice.
