Overview
Bacillus Calmette-Guerin (BCG) substrain Russian BCG-I is a live BCG vaccine administered directly into the bladder for the adjuvant treatment of papillary urothelial cell carcinoma of the bladder. Live BCG vaccines administered intravesically have been a gold standard therapy in the adjuvant treatment of non-muscle-invasive bladder cancers for decades, used after tumor resection, and are thought to work by stimulating a local immune and inflammatory response in the bladder. The live Russian BCG-I substrain of BCG was granted a notice of compliance with conditions by Health Canada in February 2021. It is to be marketed by Verity Pharmaceuticals, under the trade name VERITY-BCG, and manufactured by the Serum Institute of India. It was developed to alleviate Canada's multi-year shortage of BCG vaccine, and is expected to be available by mid-2021.
Indication
The live BCG vaccine (substrain Russian BCG-I, i.e. VERITY-BCG) is indicated for adjuvant therapy following transurethral resection of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder in stages Ta (grade 2 or 3) or T1 (grade 1, 2, or 3), without concomitant carcinoma in situ. It may also be used for stage Ta grade 1 papillary tumors, but only when the risk of recurrence is high (>50%).
Associated Conditions
- Ta Bladder Papillary Urothelial Carcinoma
- Stage T1 Bladder Papillary Urothelial Carcinoma
Clinical Trials
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No clinical trials found for this drug
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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| VERITY-BCG | 02508613 | Powder For Suspension - Intravesical | 40 MG / VIAL | 8/30/2021 |
CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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