FDA Accepts ImmunityBio's ANKTIVA sBLA for 85% of NMIBC Cases, Sets Jan. 6, 2027 Decision
Updated
Updated · ir.immunitybio.com · May 19
FDA Accepts ImmunityBio's ANKTIVA sBLA for 85% of NMIBC Cases, Sets Jan. 6, 2027 Decision
3 articles · Updated · ir.immunitybio.com · May 19
January 6, 2027 is the FDA's target date to decide whether ANKTIVA plus BCG can expand into BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.
The agency accepted the supplemental filing after ImmunityBio submitted added scientific data arguing papillary tumors and CIS share overlapping biology, supporting extrapolation from ANKTIVA's already approved CIS indication.
QUILT-3.032 Cohort B data in 80 high-grade papillary-only patients underpins the application, showing 58.2% disease-free survival at 12 months, 82.0% progression-free survival at 36 months and 83.1% cystectomy-free survival at 36 months.
FDA still flagged concerns about relying on single-arm papillary-disease data alone, even as workshop panelists and March 2026 NCCN guidance backed treating papillary disease similarly to CIS.
About 85% of the 64,000 U.S. NMIBC cases diagnosed annually present with papillary disease, a group with no FDA-approved bladder-sparing therapy to date.
As new bladder cancer drugs launch, how will doctors choose the best therapy without direct comparison trials?
Can ANKTIVA’s promising data overcome its recent FDA warning for misleading marketing claims?
ANKTIVA+BCG Sets New Benchmark in Bladder Cancer: 71% Complete Response and Durable Bladder Preservation
Overview
ANKTIVA (nogapendekin alfa inbakicept-pmln) combined with BCG has quickly become a vital new treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). After gaining approval from the US FDA in April 2024, the UK MHRA in July 2025, and the Saudi Arabia SFDA in January 2026, the European Commission authorized this therapy in February 2026 for patients with carcinoma in situ (CIS) across Europe. This marked the first time such an immunotherapy was available for this patient group in Europe, offering a much-needed alternative to radical cystectomy and setting a new standard in bladder cancer care.