03:57 AM EDT, 07/08/2025 (MT Newswires) -- ImmunityBio ( IBRX ) said Monday it has been granted UK Medicines and Healthcare products Regulatory Agency marketing authorization for Anktiva in combination with Bacillus Calmette-Guerin for the treatment of certain bladder cancer patients.

This is the first marketing approval outside the U.S. for this novel lymphocyte-stimulating agent.

Anktiva received US Food and Drug Administration UK MHRA approvals based on the outcomes of a single-arm trial of 77 evaluable patients who received the combination for up to 37 months, the company said.

ImmunityBio ( IBRX ) said it has also submitted regulatory applications for the combination to the European Medicines Agency.