ImmunityBio Secures FDA Approval for BLA for Bladder Cancer Drug, New PDUFA Date Set

Immunotherapy company, ImmunityBio (Nasdaq: IBRX) has received FDA approval for its Biologics License Application (BLA) for N-803 for the treatment of Bacille Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS). The FDA has set a user fee goal date (PDUFA date) of April 23, 2024. The company’s share price rose more than 20% following the news.

Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, said, “We are pleased that the FDA has accepted ImmunityBio’s resubmission of the BLA as a complete response, following our productive interactions leading up to the resubmission. We look forward to working closely with the Agency to finalize the review and to bringing this important immune-enhancing therapeutic to patients suffering from bladder cancer.”


N-803 is currently being evaluated in adult patients in two clinical NMIBC trials.

N-803 is designed to have improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

Bacille Calmette-Guérin (BCG) is a well-established treatment for preventing or delaying tumor recurrence following high-grade non muscle invasive bladder cancer (NMIBC) resection.

NMIBC is cancer found in the tissue that lines the inner surface of the bladder. Bladder cancer is the 6th most common cancer in the United States. 

About ImmunityBio

ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. We are applying our science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, please visit:

About the Author

ImmunityBio Secures FDA Approval for BLA for Bladder Cancer Drug, New PDUFA Date Set

Catie Corcoran

Biotech Editor