On October 14, 2026, the FDA expanded its approval of ImmunityBio's Anktiva (nogapendekin alfa inbakicept-pmln) combined with BCG to include adults with BCG-unresponsive high-grade papillary-only nonmuscle invasive bladder cancer. By extrapolating trial data from carcinoma in situ, the FDA adopted a novel regulatory strategy grounded in shared pathological features. In supporting trials, 62% of patients achieved complete responses.
FDA regulatory approvals for Anktiva
- ▪On October 14, 2026, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) in combination with Bacillus Calmette-Guérin for adults with BCG-unresponsive high-grade papillary-only nonmuscle invasive bladder cancer
- ▪The FDA granted the expanded approval of Anktiva for BCG-unresponsive high-grade papillary-only bladder cancer to Altor BioScience ahead of the expected January 6, 2027 target review date
- ▪The FDA previously approved Anktiva with Bacillus Calmette-Guérin in April 2024 for adults with BCG-unresponsive nonmuscle invasive bladder cancer presenting with carcinoma in situ, with or without papillary tumors
Scientific rationale for expanded approval
- ▪The FDA based its October 2026 expanded approval of Anktiva on clinical evidence extrapolated from efficacy data in carcinoma in situ to high-grade papillary-only bladder cancer
- ▪FDA Oncology Center of Excellence director R. Angelo de Claro stated that review of shared cancer features allowed the agency to expand treatment options for papillary tumors
- ▪High-grade papillary tumors and carcinoma in situ are aggressive urothelial carcinomas that frequently coexist, share microscopic features, and carry a high risk of recurrence after Bacillus Calmette-Guérin failure
QUILT-3.032 trial efficacy results
- ▪Anktiva's initial 2024 approval for carcinoma in situ was supported by findings from the single-arm QUILT-3.032 trial involving 77 adult patients with BCG-unresponsive high-risk NMIBC
- ▪In the QUILT-3.032 trial cohort with carcinoma in situ, 62% of patients achieved a complete response following Anktiva and Bacillus Calmette-Guérin treatment
- ▪Among complete responders in the QUILT-3.032 trial, 58% maintained their response for at least 12 months and 40% for at least 24 months after Anktiva and Bacillus Calmette-Guérin treatment
Dosage and administration schedule
- ▪Anktiva, a bladder cancer treatment, is administered at a 400 µg dose directly into the bladder via catheter alongside Bacillus Calmette-Guérin once weekly for 6 weeks as initial induction therapy
- ▪Maintenance therapy of Anktiva with Bacillus Calmette-Guérin involves 3-week weekly instillation cycles up to a maximum duration of 37 months
Adverse reactions and Safety warnings
- ▪The most common adverse reactions reported with Anktiva and Bacillus Calmette-Guérin treatment include dysuria, hematuria, urinary frequency, urinary tract infections, musculoskeletal pain, chills, pyrexia, and elevated creatinine
- ▪Prescribing information for Anktiva includes a warning that delaying surgical bladder removal can lead to metastatic cancer and fatal outcomes
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