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.
A study in Cell suggests a urine DNA test may help identify which people with non-muscle invasive bladder cancer are likely to benefit from BCG immunotherapy. The test detected minimal residual disease after surgery and BCG treatment and distinguished recurrence risk based on tumour DNA findings.
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.
ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.
ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.
ImmunityBio receives conditional EU marketing authorization for Anktiva combination therapy in bladder cancer, covering 33 countries, while establishing distribution partnerships in Saudi Arabia for bladder and lung cancer patients.
ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries following conditional EU authorization. The company established an Irish subsidiary to support European distribution and commercialization.
The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy's availability to 33 countries across four regulatory jurisdictions.
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
The European Medicines Agency recommended conditional marketing authorization for Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer in December 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07551544 |
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer |
WITHDRAWN | PHASE3 |
| NCT07505615 |
A Phase I-II Study of Novel Oncolytic Virus VG161 Via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer |
COMPLETED | PHASE1/PHASE2 |
| NCT07445308 |
The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG. |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07424287 |
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC |
NOT_YET_RECRUITING | PHASE3 |
| NCT07207824 |
DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC |
NOT_YET_RECRUITING | PHASE3 |
| NCT07064863 |
A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC. |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06991868 |
A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD) |
RECRUITING | |
| NCT06982690 |
Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial |
NOT_YET_RECRUITING | NA |
| NCT06889623 |
Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer |
RECRUITING | NA |
| NCT06810141 |
ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer |
AVAILABLE |
