ImmunityBio receives FDA refusal to file for ANKTIVA sBLA in NMIBC papillary indication

ImmunityBio, Inc.

FDA issued Refusal to File (RTF) letter on May 2, 2025 for sBLA of ANKTIVA+BCG in BCG-unresponsive papillary NMIBC.
Company cites unanimous January 2025 FDA leadership guidance encouraging sBLA submission; RTF called inconsistent.
Existing approval for CIS +/- papillary (Cohort A) is unaffected; RTF pertains to papillary without CIS (Cohort B).
Data highlighted: 96% disease-specific survival at 36 months and >82% bladder-sparing rate in the papillary cohort.
Company requests urgent Type A meeting with FDA; former FDA Principal Deputy Commissioner Dr. Sherman supports appeal.

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