BCG (Bacillus Calmette-Guérin) is a live attenuated biologic used as a tuberculosis vaccine and as intravesical immunotherapy for non-muscle invasive bladder cancer. It is a long-established medical product with both preventive and therapeutic indications. In the U.S., BCG products are prescription-only.
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.
Biopharma companies face a $275b patent cliff as licensing activity shifts toward China. China represented almost half of 2025 licensing activity and contributes about 30% of the global biotech pipeline.
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.
A vaccine and two novel tuberculosis treatments are advancing through Phase III trials, marking renewed momentum in TB research. Tuberculosis claims over 1.25 million lives annually with 10.6 million new cases in 2023, while current treatments face challenges of high pill burden, toxicity, and rising resistance.
ImmunityBio reported a fivefold revenue increase to $38.29 million, driven by a 750% surge in unit sales of its cancer drug Anktiva. The company is expanding internationally through partnerships in the Middle East and preparing additional FDA submissions for Anktiva's broader use.
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.
Hyderabad-based CRDMO Sai Life Sciences plans to recruit over 700 scientific, technical, and management professionals during 2026-27, representing a 20% workforce expansion driven by growing global demand for integrated drug discovery and manufacturing services.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07206225 |
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer |
RECRUITING | PHASE1 |
| NCT06833073 |
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) |
RECRUITING | PHASE2 |
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A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi |
NOT_YET_RECRUITING | NA |
| NCT06050356 |
First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT05947890 |
Evaluating the Safety and Immunogenicity of MTBVAC |
RECRUITING | PHASE2 |
| NCT05943106 |
BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05675176 |
Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer |
COMPLETED | |
| NCT05626101 |
Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study |
RECRUITING | NA |
| NCT05541952 |
BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population |
WITHDRAWN | PHASE4 |
| NCT05471167 |
Non-specific Effects of BCG in Under-five Children |
UNKNOWN |
