After a momentous 2024, Culver City-based ImmunityBio Inc., the immunotherapy company founded and majority-owned by billionaire biotech entrepreneur Patrick Soon-Shiong, has had a busy start to the year.

Last April, ImmunityBio achieved a major milestone when the U.S. Food and Drug Administration approved its lead drug candidate, Anktiva, to treat certain types of bladder cancers. That allowed the company to start marketing the drug within the United States.

Now, ImmunityBio is trying to take its Anktiva drug to Europe. On Jan. 27, ImmunityBio announced that the European Medicines Agency – the European Union’s equivalent to the FDA – had accepted its marketing authorization application for Anktiva for the same use as in the United States: treatment of patients with a type of bladder cancer. If the EMA approves the drug, ImmunityBio can market it in European Union’s 27 member countries, including major markets France and Germany.

UK accepts drug application

Roughly two weeks later, ImmunityBio announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency had accepted its application to market the drug within the United Kingdom.

Decisions on both marketing applications are expected later this year or possibly early next year; the FDA approval already garnered is expected to help speed this process.

Separately, on Jan. 29, ImmunityBio announced it has entered into a collaboration and supply agreement with BeiGene to conduct a Phase 3 clinical trial, combining Anktiva with BeiGene’s immunotherapy drug tislelizumab.