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Bacillus Calmette-Guérin (BCG)
BCG is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and destroy cancer cells, particularly in the bladder.
BCG is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and destroy cancer cells, particularly in the bladder. Used for Non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ, High-grade urothelial carcinoma of the bladder.
At a glance
| Generic name | Bacillus Calmette-Guérin (BCG) |
|---|---|
| Also known as | BCG, BCG SSI |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Drug class | Live attenuated vaccine / Immunotherapy |
| Target | Pattern recognition receptors (TLR2, TLR4, NOD2); non-specific immune activation |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BCG works by activating innate and adaptive immune responses through pattern recognition receptors on immune cells. When instilled directly into the bladder, it triggers local inflammation and recruitment of immune cells that target bladder cancer cells. This immunotherapy approach has been the gold standard for non-muscle-invasive bladder cancer for decades.
Approved indications
- Non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ
- High-grade urothelial carcinoma of the bladder
Common side effects
- Dysuria (painful urination)
- Urinary frequency
- Hematuria (blood in urine)
- Fever
- Malaise/fatigue
- BCG sepsis (rare but serious)
Key clinical trials
- Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) (PHASE3)
- A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) (PHASE3)
- A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) (PHASE3)
- A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (PHASE2)
- A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (PHASE3)
- Intravesical Gem/Doce in Patients With NMIBC (PHASE2)
- A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) (PHASE2)
- Immunization With BCG Vaccine to Prevent Tuberculosis Infection (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bacillus Calmette-Guérin (BCG) CI brief — competitive landscape report
- Bacillus Calmette-Guérin (BCG) updates RSS · CI watch RSS
- Memorial Sloan Kettering Cancer Center portfolio CI