The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to N-803 (ImmunityBio), in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ (CIS).

N-803 is an interleukin-15 (IL-15) superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. N-803 has demonstrated to improve pharmacokinetic properties with longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo. 

The designation was based on results from phase 1 and 2 studies. ImmunityBio Chief Medical Officer, Dr. John Lee commented, “The favorable safety profile and initial efficacy results from our phase 1 study strongly suggest we may be able to improve the treatment for a disease that has not had non-surgical treatment options for over 30 years.”


The FDA previously granted Fast Track designation to N-803 in 2017. The Company is currently evaluating N-803 in 2 clinical trials (QUILT 2.005 and QUILT 3.032) for adult patients with non-muscle invasive bladder carcinoma.


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“We are pleased that the FDA has granted Breakthrough Therapy Designation to N-803 in combination with BCG for the treatment of patients with Non-Muscle Invasive Bladder Cancer with CIS,” said Dr Patrick Soon-Shiong, Chairman and CEO of ImmunityBio. “We look forward to accelerating our work on N-803 to bring greater hope to the thousands of people living with the serious consequences of bladder cancer and to address the unmet need to avoid surgical removal of the bladder in these high-risk patients.”

For more information visit immunitybio.com.