Bacillus calmette-guerin substrain russian BCG-I live antigen
- Generic Name
- Bacillus calmette-guerin substrain russian BCG-I live antigen
- Brand Names
- VERITY-BCG
- Drug Type
- Biotech
- Unique Ingredient Identifier
- 6NDGUCSPCL
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.
Background
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|
No FDA products found
No FDA products found for this drug
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. | Online |
|---|
No Singapore products found
No Singapore products found for this drug
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|
No China products found
No China products found for this drug
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|
No Australia products found
No Australia products found for this drug