ImmunityBio Advances FDA Talks on Potential Resubmission in Bladder Cancer

 

• Following discussions with the U.S. FDA, the Agency recommended that the Company submit additional information for its evaluation of this information to potentially support a resubmission of the sBLA for BCG-unresponsive papillary NMIBC
• The additional information does not include the initiation or design of any new clinical trials, and the Company will provide the requested information in the next 30 days
• Long-term data published in The Journal of Urology evaluating ANKTIVA in patients with papillary disease (N=80) demonstrate approximately 96% bladder cancer-specific survival and greater than 80% bladder preservation at three years, with median outcomes not yet reached
• ImmunityBio commercially launched ANKTIVA for NMIBC CIS with or without papillary tumors in the United States and has since expanded approvals to the United Kingdom and Saudi Arabia, with conditional approval in the European Union

https://www.businesswire.com/news/home/20260120371998/en/ImmunityBio-Advances-Regulatory-Discussions-with-FDA-on-Potential-Resubmission-Path-for-ANKTIVA-in-BCG-Unresponsive-Papillary-Bladder-Cancer