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BCG instillation therapy
BCG instillation therapy stimulates the local immune system in the bladder to recognize and destroy cancer cells.
BCG instillation therapy stimulates the local immune system in the bladder to recognize and destroy cancer cells. Used for Non-muscle-invasive bladder cancer (NMIBC), high-grade or recurrent, Carcinoma in situ (CIS) of the bladder.
At a glance
| Generic name | BCG instillation therapy |
|---|---|
| Also known as | BCG, BCG-MEDAC, OncoTICE, ImmuCyst, TheraCys |
| Sponsor | Turku University Hospital |
| Drug class | Immunotherapy vaccine |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Bacillus Calmette-Guérin (BCG) is a live attenuated mycobacterium administered directly into the bladder where it triggers a robust local immune response, activating dendritic cells, macrophages, and T cells to target and eliminate bladder cancer cells. This immunotherapy approach has been the gold standard for non-muscle-invasive bladder cancer for decades, though the exact mechanisms of anti-tumor immunity remain incompletely understood.
Approved indications
- Non-muscle-invasive bladder cancer (NMIBC), high-grade or recurrent
- Carcinoma in situ (CIS) of the bladder
Common side effects
- Dysuria (painful urination)
- Urinary frequency
- Hematuria (blood in urine)
- Fever
- Systemic BCG infection (rare)
Key clinical trials
- Early vs Delayed Intravesical Blad-Care During BCG Therapy (NA)
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer. (PHASE1)
- Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer (PHASE3)
- Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC (PHASE2)
- A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy (PHASE3)
- Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin (PHASE3)
- A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer (PHASE1)
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:
- BCG instillation therapy CI brief — competitive landscape report
- BCG instillation therapy updates RSS · CI watch RSS
- Turku University Hospital portfolio CI