ImmunityBio’s Bladder Cancer Immunotherapy gets an FDA Approval
ImmunityBio announced that the U.S. Food and Drug Administration has accepted its Biologics License Application (BLA) for N-803, a specific form of bladder cancer. N-803 is an antibody cytokine fusion protein. The BLA is for the use of the drug with Bacillus Calmette-Guerin (BCG) to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma (NMIBC) in situ (CIS) with or without Ta or T1 disease. ImmunityBio’s N-803 has received Breakthrough therapy and fast-track designations by the FDA for BCG-unresponsive NMIBC CIS and Fast Track designation for BCG-unresponsive NMIBC papillary and BCG-naive NMIBC CIS,
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