The U.S. Food and Drug Administration (FDA) has accepted ImmunityBio’s IBRX Biologics License Application (BLA) for review for its lead product N-803 in the treatment of patients with non-responsive BCG-non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease.
The regulatory body has assigned a target action date of May 23, 2023.
The BLA’s submission is supported by the results of its bladder cancer trials, including QUILT 3,032 Phase 2/3 trial of intravesical BCG plus N-803 in patients with BCG-unresponsive high-quality NMIBC.
Richard Adcock, President and CEO, commented: “We are pleased that the FDA has begun the review and ImmunityBio is ready to move quickly to manufacturing and marketing if the Agency approves our drug for this indication.”
The company indicated that the combination of N-803 with BCG is the first BLA to reach this stage of FDA approval for review.
Previously, the agency has awarded N-803, Breakthrough Therapy and Fast Track designations in conjunction with Bacillus Calmette-Guérin (BCG).
Price action: ImmunityBio shares traded about 4 percent higher at $4.44 during the after-hours session Thursday.
This post FDA Accepts ImmunityBio’s Bladder Cancer Candidate for Review was original published at “https://www.benzinga.com/general/biotech/22/07/28257507/fda-accepts-immunitybios-bladder-cancer-candidate-for-review”