Intravesical BCG
A weakened tuberculosis vaccine put directly into the bladder. Since 1976 it has been the most effective treatment for early bladder cancer, and it remains in chronic short supply.
Induction (6 weekly instillations) plus 1-3 years of maintenance reduces recurrence and progression in high-risk NMIBC. Global shortages since 2012 (single US manufacturer, Merck) have forced dose-splitting and priority rules. New combinations: durvalumab + BCG (POTOMAC, approved 2026), N-803 + BCG (Anktiva, 2024), and recombinant BCG (VPM1002) in trials. About 30-40% of patients become BCG-unresponsive.
1.BCG binds fibronectin on disrupted urothelium and is internalised by tumour cells
- Route
- Intravesical
- Schedule
- Weekly ×6 induction, then 3 weekly instillations at months 3, 6, 12, 18, 24, 30, 36 (SWOG maintenance) for high-risk disease
- Dose modifications
- Reduced (one-third) dose during shortages; hold for haematuria, UTI, or systemic symptoms
- Monitoring
- Cystoscopy and cytology every 3 months for 2 years
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 1990 | Carcinoma in situ of the bladder (TICE BCG) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Cystitis symptoms | 70% | — |
| Haematuria | 25% | — |
| Fever | 20% | — |
| Systemic BCG infection | 1% | — |
Rare; requires anti-tuberculous therapy. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Intravesical BCG" OR ABSTRACT:"Intravesical BCG" OR TITLE:"TICE BCG" OR ABSTRACT:"TICE BCG") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Intravesical BCG, not a curated reading list.
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