# ANKTIVA (nogapendekin alfa inbakicept-pmln) + BCG PDUFA Event: BCG-unresponsive non-muscle invasive bladder cancer with papillary disease without carcinoma in situ

Canonical URL: https://biopharmsignal.com/pdufa-calendar/IBRX/anktiva-bcg-papillary-nmibc

Ticker: IBRX

Company: ImmunityBio

Event date: 2027-01-06

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sBLA

FDA decision expected. FDA assigned January 6, 2027 as the PDUFA target action date for the ANKTIVA plus BCG supplemental BLA.

## Event Timeline

### January 6, 2027 — FDA decision expected

FDA assigned January 6, 2027 as the PDUFA target action date for the ANKTIVA plus BCG supplemental BLA.

[ImmunityBio — sBLA acceptance and PDUFA date](https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-fda-acceptance-supplemental-bla-anktivar)

### May 19, 2026 — FDA accepted the sBLA for review

The application seeks to expand ANKTIVA plus BCG to adults with BCG-unresponsive NMIBC and papillary disease without CIS.

[ImmunityBio — sBLA acceptance](https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-fda-acceptance-supplemental-bla-anktivar)

### May 19, 2026 — QUILT 3.032 data supported the filing

In the 80-patient papillary-only cohort, the Phase 2/3 study reported 58.2% disease-free survival at 12 months.

[ImmunityBio — QUILT 3.032 data summary](https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-fda-acceptance-supplemental-bla-anktivar)

## Related Pages

- IBRX PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/IBRX.md

- IBRX company profile: https://biopharmsignal.com/company/IBRX.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-08-10 — ImmunityBio Appoints Dr. Jim Yong Kim, Former World Bank President and Global Health Leader, as Vice Chairman: https://biopharmsignal.com/news/IBRX/immunitybio-appoints-dr-jim-yong-kim-former-world-bank-president-and-global-heal-21f34ec3.md

- 2026-08-04 — ImmunityBio Reports Record Q2 2026 Net Product Revenue of $50.7 Million, Up 92% Year-Over-Year; First-Half Revenue Up 121% to $94.8 Million: https://biopharmsignal.com/news/IBRX/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-yea-a886a63e.md

- 2026-07-29 — ImmunityBio Receives United Arab Emirates (UAE) Marketing Authorization for ANKTIVA® Across BCG-Unresponsive Non-Muscle Invasive Bladder Cancer for CIS and Papillary Disease and Metastatic Non-Small Cell Lung Cancer: https://biopharmsignal.com/news/IBRX/immunitybio-receives-united-arab-emirates-uae-marketing-authorization-for-anktiv-9a6a04b3.md

- 2026-06-01 — ImmunityBio Presents New Clinical and Comparative Data Across Lung and Bladder Cancer at ASCO 2026: https://biopharmsignal.com/news/IBRX/immunitybio-presents-new-clinical-and-comparative-data-across-lung-and-bladder-cancer-at-asco-2026.md

- 2026-05-22 — ImmunityBio Highlights Patient Survey Data at ISPOR 2026 Showing Majority of UK Adults Living with NMIBC Favor Bladder Preservation: https://biopharmsignal.com/news/IBRX/immunitybio-highlights-patient-survey-data-at-ispor-2026-showing-majority-of-uk-adults-living-with-nmibc-favor-bladder-preservation.md