ImmunityBio Advances rBCG Submission as Anktiva Revenues Surge 700%
ImmunityBio advanced regulatory discussions with the Saudi FDA to submit its recombinant BCG package in coming weeks, targeting expanded bladder cancer treatment access in Saudi Arabia. Its Anktiva therapy generated about $113 million in fiscal 2025 net product revenue, a 700% year-over-year surge supported by Phase 2b NSCLC trial data.
1. Saudi FDA Discussions for rBCG
ImmunityBio engaged the Saudi Food and Drug Authority in productive discussions for submission of its recombinant BCG regulatory package aimed at alleviating the global BCG shortage and expanding bladder cancer treatment access in Saudi Arabia, with plans to file in the coming weeks.
2. Anktiva Revenue Growth
The company reported approximately $113 million in net product revenue for its Anktiva (nogapendekin alfa inbakicept) therapy in fiscal 2025, representing a 700% year-over-year increase, and intends to submit additional information to the U.S. FDA within 30 days for a supplemental biologics license application in papillary non-muscle invasive bladder cancer.
3. QUILT-3.055 Clinical Trial Data
Data from the QUILT-3.055 Phase 2b basket trial (N=147) support expansion of Anktiva in combination with checkpoint inhibitors across several tumor types; in the NSCLC cohort (N=86), Anktiva addition yielded a median overall survival of 14.1 months and 12- and 18-month survival rates of 57% and 34%, respectively.