FDA Expands Approval for Nogapendekin Alfa in BCG-Unresponsive NMIBC

An expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva) in combination with Bacillus Calmette-Guérin (BCG) has been approved by the FDA for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The approval revises the prior indication for those with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. It now includes patients with high-grade papillary tumors. Furthermore, the FDA found overlapping clinical and non-clinical features between high-grade papillary and CIS tumors. The FDA concluded that for patients with BCG-unresponsive NMIBC containing CIS, the efficacy could be extrapolated to those with BCG-unresponsive high-grade papillary disease.

The approval was based on results from cohort A of the phase 2/3 QUILT-3.032 (NCT03022825) trial assessing 77 patients with BCG-unresponsive high-risk NMIBC with CIS with or without Ta/T1 papillary disease after transurethral resection. Administration of nogapendekin alfa inbakicept was given as induction via intravesical instillation with BCG and followed by maintenance therapy for up to 37 months.

Topline efficacy data include complete responses (CR) determined by cystoscopy, urine cytology, and biopsy. The CR rate was 62% (95% CI, 51%-73%). Of note, 58% of patients had a CR with a duration of response (DOR) of 12 months or more, and 40% had a CR with a DOR of 24 months or more.

The recommended dose is 400 mcg given intravesically with BCG once a week for 6 weeks as induction therapy. If a patient has residual CIS and/or high grade Ta tumor at month 3, a second induction course may be given.

Maintenance after induction will be given at the 400 mcg recommended dose given intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13, and 19. This will continue for a total of 15 doses. If patients have no evidence of high-grade disease at month 25 and later, maintenance instillations with BCG may be given once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 instillations.

The most common adverse effects included laboratory test abnormalities and consisted of increased creatinine, dysuria, hematuria, urinary frequency, and micturition urgency.

Reference

FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. FDA. October 14, 2026. Accessed October 14, 2026. https://tinyurl.com/38cp583x