- ImmunityBio ( NASDAQ: IBRX ) on Thursday said the U.S. FDA had accepted for review the company's biologics license application (BLA) for its agonist N-803 for the treatment of bladder cancer carcinoma in situ.
- The exact indication for N-803 is for the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
- "In situ" in cancer terminology refers to a group of abnormal, potentially cancerous cells that are found only in the place where they first formed in the body.
- The FDA is set to decide on the BLA by May 23, 2023, or the so-called Prescription Drug User Fee Act date.
- IBRX said the FDA's acceptance represents the first regulatory filing for N-803.
- ImmunityBio ( IBRX ) stock +1.4% to $4.34 after hours.
For further details see:
FDA accepts ImmunityBio's biologics license application for bladder cancer treatment N-803