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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.

Schematic of the modality · Live bacterial immunotherapy (intravesical) · not a molecule; see the Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy) page
Mechanism, step by step
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1.BCG binds fibronectin on disrupted urothelium and is internalised by tumour cells

Modality
Live bacterial immunotherapy (intravesical)
Mechanism
Attaches to urothelium via fibronectin, is internalised, and triggers a Th1 innate and adaptive immune response with trained immunity.
Brand / code
TICE BCG
Dosing & schedule
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

Regulatory

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Approvals

RegionYearIndication
US1990Carcinoma in situ of the bladder (TICE BCG)

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
105 studies23 recruiting64 Phase 239 Phase 3
Search “Intravesical BCG” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Intravesical BCG
intervention: Intravesical BCG
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend90 papers in the last 12 months+34% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query 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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