ImmunityBio receives EMA positive opinion for ANKTIVA+BCG in NMIBC CIS in Europe

ImmunityBio, Inc.

EMA recommends conditional marketing authorization for ANKTIVA+BCG to treat BCG-unresponsive NMIBC with CIS.
Decision based on single-arm trial: 71% complete response rate, median duration ~27 months (up to 54+ months).
Over 150,000 Europeans diagnosed with NMIBC annually; no authorized treatment currently for BCG-unresponsive cases.
Opinion forwarded to European Commission for final EU-wide approval; company to submit long-term follow-up data.
Six BCG strains available in Europe; ImmunityBio developing recombinant BCG to address U.S. shortages.

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