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ImmunityBio Slapped With FDA Refusal To File Letter For Expanded Use Of Its Bladder Cancer Drug
Benzinga· 2025-05-05 13:21
ImmunityBio, Inc. IBRX on Monday received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. Data was also presented on the long-term follow-up Phase 1 results, which demonstrated Complete Response and Disease-Free Survival in both CIS and Papillary disease, with pa ...