ImmunityBio is a biotechnology company developing innovative immunotherapies for cancer and infectious diseases. It focuses on therapies designed to work with and protect the immune system while advancing a broad clinical pipeline.
The bladder cancer therapeutics market is expanding with recent FDA approvals including INLEXZO for NMIBC and a KEYTRUDA-Padvev combination for MIBC, while the NMIBC market reached approximately USD 3 billion in 2025 across seven major markets. Ferring reported record revenues exceeding €2.5 billion in 2025, driven by Adstiladrin as its second major growth driver. A robust pipeline of emerging therapies is expected to further transform the market through 2036.
New clinical data for ANKTIVA immunotherapy in lung cancer, a study on EBV-driven resistance via ADAR1 RNA editing, and research on microbiome metabolites modulating immunotherapy response were presented at major conferences and in recent publications.
ImmunityBio said the FDA accepted its sBLA for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. The PDUFA date is Jan. 6, 2027.
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.
Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.
The National Comprehensive Cancer Network has updated its bladder cancer guidelines to include ImmunityBio's Anktiva plus BCG for BCG-unresponsive papillary-only disease. The Category 2A recommendation expands treatment options beyond the drug's initial FDA approval for carcinoma in situ. ImmunityBio also announced its pivotal trial is adequately powered and European distribution partnerships to expand global access.
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
The immuno-oncology market is projected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, driven by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines, with North America commanding 43% market share.
ImmunityBio establishes wholly owned subsidiary in Saudi Arabia to distribute Anktiva for bladder and lung cancer across MENA region, following world's first lung cancer approval in the Kingdom less than a year after May 2025 meeting.
