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ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease

on May 20, 2026

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ImmunityBio has announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors, and has set a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2027.

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FDA approves nogapendekin alfa inbakicept-pmln for bladder cancer

ImmunityBio, Inc. - 725468 - 03/13/2026 | FDA

ImmunityBio Announces FDA Submissions of Supplemental BLA for ...

Therapeutic Advances in Bladder Preservation for BCG ... - PMC - NIH

ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA® to Treat Lymphopenia – Company Announcement

Transforming non-muscle invasive bladder cancer (NMIBC) treatment

FDA Approves Nogapendekin Alfa-inbakicept/BCG in ...

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ImmunityBio Announces Resubmission of Supplemental BLA to the ...

ANKTIVA® with BCG Demonstrates 96% Survival ...

ImmunityBio Announces FDA Submissions of ...

acceptance Anktiva BCG-unresponsive Blackfoot language ImmunityBio Non-Muscle Invasive Bladder Neoplasms Papillary Disease PDUFA Supplement United States Food and Drug Administration

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