ImmunityBio gets EC approval for ANKTIVA+BCG in NMIBC CIS; now authorized in 33 countries

ImmunityBio, Inc.

EC conditional marketing authorization for ANKTIVA+BCG in BCG-unresponsive NMIBC CIS; 71% complete response rate, median DOR 26.6 months.
Approval covers all 27 EU member states plus Iceland, Norway, Liechtenstein; total authorized countries now 33.
First immunotherapy authorized in Europe for this indication; prior standard of care was radical cystectomy.
Authorization based on QUILT-3.032 phase 2/3 trial; ImmunityBio to submit long-term safety and efficacy data as condition.
Global regulatory footprint built in under 2 years from initial FDA approval in April 2024.

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