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Bacillus Calmette-Guerin (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, Bladder cancer prophylaxis after transurethral resection.
At a glance
| Generic name | Bacillus Calmette-Guerin (BCG) |
|---|---|
| Also known as | Tice BCG |
| Sponsor | Massachusetts General Hospital |
| Drug class | Live attenuated vaccine / Immunotherapy |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
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. The exact mechanism involves activation of dendritic cells, T cells, and natural killer cells that recognize tumor-associated antigens.
Approved indications
- Non-muscle invasive bladder cancer (NMIBC), including carcinoma in situ
- Bladder cancer prophylaxis after transurethral resection
Common side effects
- Dysuria
- Urinary frequency
- Hematuria
- Fever
- Malaise
- BCG sepsis (rare)
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (PHASE2)
- A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) (PHASE1, PHASE2)
- ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG (PHASE1, PHASE2)
- Early vs Delayed Intravesical Blad-Care During BCG Therapy (NA)
- A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (PHASE2)
- S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (PHASE3)
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) (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-Guerin (BCG) CI brief — competitive landscape report
- Bacillus Calmette-Guerin (BCG) updates RSS · CI watch RSS
- Massachusetts General Hospital portfolio CI