The U.S. Food and Drug Administration (FDA) accepted for review ImmunityBio’s IBRX Biologics License Application (BLA) for its lead asset N-803 in the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease.
The regulatory agency has assigned a target action date of May 23, 2023.
The BLA submission is supported by the results from its bladder cancer trials including QUILT 3.032 Phase 2/3 study of intravesical BCG plus N-803 in patients with BCG-unresponsive high-grade NMIBC.
Richard Adcock, President and CEO, commented: ”We are pleased the FDA has begun its review, and ImmunityBio is prepared to move rapidly to manufacturing and marketing should the Agency approve our therapeutic for this indication.”
The company indicated that the combination of N-803 with BCG is the first BLA to reach this stage of FDA acceptance for review.
Previously, the agency has granted N-803, Breakthrough Therapy and Fast Track designations in combination with Bacillus Calmette-Guérin (BCG).
Price Action : ImmunityBio shares are trading around 4 percent higher at $4.44 on Thursday during after-hours session.
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