{"entity":{"id":"bcg-intravesical","kind":"drug","name":"Intravesical BCG","aka":[],"tldr":"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.","summary":"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.","status":"standard-of-care","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/BCG_vaccine","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/BCG_vaccine"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["bcg-and-intravesical-therapy"],"targets":[],"drugs":[],"companies":["merck"],"institutions":[],"pathways":[],"terms":["nmibc-vs-mibc","bcg-unresponsive"],"trials":["potomac","quilt-3-032"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"TICE BCG","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.","approvals":[{"region":"US","year":1990,"indication":"Carcinoma in situ of the bladder (TICE BCG)"}],"mechanismSteps":["BCG binds fibronectin on disrupted urothelium and is internalised by tumour cells","Cytokine release (IL-2, IFN-γ, TNF) recruits neutrophils, macrophages, and T cells","Trained innate immunity and BCG-specific T cells eliminate residual tumour","Repeated maintenance instillations sustain the response"],"dosing":{"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","modifications":"Reduced (one-third) dose during shortages; hold for haematuria, UTI, or systemic symptoms","monitoring":"Cystoscopy and cytology every 3 months for 2 years"},"toxicity":[{"event":"Cystitis symptoms","anyGradePct":70},{"event":"Haematuria","anyGradePct":25},{"event":"Fever","anyGradePct":20},{"event":"Systemic BCG infection","anyGradePct":1,"note":"Rare; requires anti-tuberculous therapy"}],"access":[],"regulatoryEvents":[]},"route":"/drugs/bcg-intravesical/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"}],"technology":[{"id":"bcg-vaccine-manufacturing","kind":"technology","name":"BCG manufacturing and the bladder cancer BCG shortage","route":"/technologies/bcg-vaccine-manufacturing/"},{"id":"bladder-epicheck","kind":"technology","name":"Bladder EpiCheck urine methylation test","route":"/technologies/bladder-epicheck/"},{"id":"bcg-and-intravesical-therapy","kind":"technology","name":"Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)","route":"/technologies/bcg-and-intravesical-therapy/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"term":[{"id":"bcg-unresponsive","kind":"term","name":"BCG-unresponsive","route":"/terms/bcg-unresponsive/"},{"id":"nmibc-vs-mibc","kind":"term","name":"Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC)","route":"/terms/nmibc-vs-mibc/"}],"trial":[{"id":"potomac","kind":"trial","name":"POTOMAC","route":"/trials/potomac/"},{"id":"quilt-3-032","kind":"trial","name":"QUILT 3.032","route":"/trials/quilt-3-032/"}],"pairing":[{"id":"durvalumab-plus-bcg","kind":"pairing","name":"Durvalumab + BCG in BCG-naive high-risk NMIBC","route":"/pairings/durvalumab-plus-bcg/"}],"idea":[{"id":"idea-bio2-engineered-bacteria-payloads","kind":"idea","name":"Engineered bacteria that live in tumours and manufacture drugs there","route":"/ideas/idea-bio2-engineered-bacteria-payloads/"},{"id":"idea-bio2-trained-immunity-priming","kind":"idea","name":"Train the bone marrow to make better anti-tumour immune cells","route":"/ideas/idea-bio2-trained-immunity-priming/"}],"pathway":[{"id":"myeloid-suppression-axis","kind":"pathway","name":"Myeloid suppression: TAMs, MDSCs & don't-eat-me signals","route":"/pathways/myeloid-suppression-axis/"}]}}