FDA Approves Nogapendekin Alfa Inbakicept Plus BCG for High-Grade, Papillary-Only BCG-Unresponsive NMIBC

The FDA has approved nogapendekin alfa inbakicept-pmln (Anktiva) in combination with BCG for the treatment of adult patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with high-grade papillary-only tumors.¹

This regulatory decision expands the prior indication for this regimen, which was for adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors.

The current approval was based on data from cohort A of the single-arm phase 2/3 QUILT-3.032 trial (NCT03022825), in which patients who received nogapendekin alfa inbakicept plus BCG (n = 77) achieved a complete response (CR) rate of 62% (95% CI, 51%-73%). Additionally, 58% of patients who achieved a CR had a duration of response (DOR) lasting at least 12 months, and 40% of patients who achieved a CR had a DOR lasting at least 24 months.

Notably, these same QUILT-3.032 data supported the 2024 FDA approval of the combination for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors.² Based on the overlapping clinical and nonclinical features of high-grade papillary NMIBC vs NMIBC with CIS, the FDA decided that the prior demonstration of efficacy in the CIS cohort could be extrapolated to patients with BCG-unresponsive, high-grade, papillary-only NMIBC.¹

What was the design of QUILT-3.032?

This multicenter trial enrolled patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary tumors who had previously undergone transurethral resection. Patients were treated with nogapendekin alfa inbakicept induction via intravesical instillation with BCG followed by maintenance therapy for a maximum of 37 months. The main efficacy end point was CR, as determined by cystoscopy, urine cytology, and biopsy. DOR served as an additional efficacy end point.

What is the safety profile of nogapendekin alfa inbakicept in NMIBC?

The most common AEs occurring in at least 15% of patients in cohort A of QUILT-3.032 included increased creatinine levels, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium levels, musculoskeletal pain, chills, and pyrexia.

What is the regulatory history of nogapendekin alfa inbakicept in papillary-only NMIBC?

In April 2025, the FDA received an sBLA seeking the approval of nogapendekin alfa inbakicept plus BCG for the treatment of patients with BCG-unresponsive papillary NMIBC.³ This sBLA was supported by data from cohort B of QUILT-3.032, which enrolled patients with papillary NMIBC.

In May 2025, the FDA issued a refusal to file letter in response to the sBLA.⁴ Following a Type B End-of-Phase meeting between ImmunityBio (the developer of nogapendekin alfa inbakicept) and the FDA regarding the initial sBLA, in which the FDA recommended additional information, the sBLA was resubmitted and included long-term data from cohort B of QUILT-3.032.^5,6

References

1. FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. FDA. October 14, 2026. Accessed October 14, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle?utm_medium=email&utm_source=govdelivery
2. FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. FDA. April 22, 2024. Accessed October 14, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer
3. ImmunityBio announces FDA submissions of supplemental BLA for NMIBC papillary disease and for expanded access of Anktiva to treat lymphopenia. News release. ImmunityBio. April 15, 2025. Accessed October 14, 2026. https://immunitybio.com/immunitybio-announces-fda-submissions-of-supplemental-bla-for-nmibc-papillary-disease-and-for-expanded-access-of-anktiva-to-treat-lymphopenia/
4. ImmunityBio requests an urgent meeting with FDA to address the change in the Agency’s unambiguous guidance on Jan 2025 to submit a sBLA for NMIBC BCG unresponsive papillary disease, following an inconsistent refusal to file letter on May 2, 2025. ImmunityBio, Inc. May 5, 2025. Accessed October 14, 2026. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-requests-urgent-meeting-fda-address-change-agencys?field_nir_news_date_value[min]=
5. ImmunityBio advances regulatory discussions with FDA on potential resubmission path for Anktiva in BCG-unresponsive papillary bladder cancer. News release. ImmunityBio January 20, 2026. Accessed October 14, 2026. https://immunitybio.com/immunitybio-advances-regulatory-discussions-with-fda-on-potential-resubmission-path-for-anktiva-in-bcg-unresponsive-papillary-bladder-cancer/
6. ImmunityBio announces resubmission of supplemental BLA to the FDA for Anktiva plus BCG in BCG-unresponsive NMIBC with papillary disease following agency review of additional data. News release. ImmunityBio. March 9, 2026. Accessed October 14, 2026. https://immunitybio.com/immunitybio-announces-resubmission-of-supplemental-bla-to-the-fda-for-anktiva-plus-bcg-in-bcg-unresponsive-nmibc-with-papillary-disease-following-agency-review-of-additional-data/