Posted by Michael Wonder on 16 Jan 2025
ImmunityBio provides regulatory update on global submission for Anktiva + BCG in BCG unresponsive non-muscle invasive bladder cancer with carcinoma in situ in Europe and United Kingdom
15 January 2025 - ImmunityBio responding to requests for information from both Agencies and the potential for approval in European Union and United Kingdom by 2026.
ImmunityBio today announced the completion of the submissions of its marketing authorisation applications for Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors, to both the European Union EMA and the United Kingdom's MHRA.
