Difference between revisions of "BCG vaccine"
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*1990-05-22: Initial approval for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder | *1990-05-22: Initial approval for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder | ||
*1990-05-22: Initial approval for the prophylaxis of primary or recurrent stage Ta and/or T1 [[bladder cancer|papillary tumors]] following transurethral resection (TUR). ''(Based on SWOG 8216 & SWOG 8507)'' | *1990-05-22: Initial approval for the prophylaxis of primary or recurrent stage Ta and/or T1 [[bladder cancer|papillary tumors]] following transurethral resection (TUR). ''(Based on SWOG 8216 & SWOG 8507)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *EURD: 1988-03-02 | ||
==Also known as== | ==Also known as== | ||
*'''Generic name:''' Bacille Calmette–Guérin | *'''Generic name:''' Bacille Calmette–Guérin | ||
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*[[Category:Non-small cell lung cancer medications (historic)]] | *[[Category:Non-small cell lung cancer medications (historic)]] | ||
| − | [[Category:FDA approved | + | [[Category:FDA approved in 1990]] |
| + | [[Category:EMA approved in 1988]] | ||
Revision as of 11:07, 13 June 2023
General information
Class/mechanism: Live mycobacteria which promote a local acute inflammatory and sub-acute granulomatous reaction with macrophage and leukocyte infiltration in the urothelium and lamina propria of the urinary bladder. This results in a likely T-lymphocyte dependent anti-tumor effect.[1][2]
Route: Intravesicular
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
- Bladder cancer (intravesicular use)
Diseases for which it was used
- B-cell acute lymphoblastic leukemia
- Breast cancer
- Colon cancer
- Diffuse large B-cell lymphoma
- Hodgkin lymphoma
- Melanoma
- Non-small cell lung cancer
Patient drug information
- Bacillus Calmette-Guérin (BCG) package insert
- Bacillus Calmette-Guérin (BCG) patient drug information (Chemocare)[3]
- Patient information about bladder cancer treatment, including BCG (UpToDate)[4]
History of changes in FDA indication
- 1990-05-22: Initial approval for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder
- 1990-05-22: Initial approval for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). (Based on SWOG 8216 & SWOG 8507)
History of changes in EMA indication
- EURD: 1988-03-02
Also known as
- Generic name: Bacille Calmette–Guérin
- Brand names: TheraCys, TICE BCG
References
- Drugs
- Intravesical medications
- Immunotherapeutic
- T-cell activators
- Bladder cancer medications
- B-cell acute lymphoblastic leukemia medications (historic)
- Breast cancer medications (historic)
- Colon cancer medications (historic)
- Diffuse large B-cell lymphoma medications (historic)
- Classical Hodgkin lymphoma medications (historic)
- Melanoma medications (historic)
- Non-small cell lung cancer medications (historic)
- FDA approved in 1990
- EMA approved in 1988