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Tice Bcg (bcg)
BCG is a marketed drug by Pfizer Inc. for the treatment of bladder cancer. It is used to treat superficial bladder cancer, carcinoma in situ (CIS) of the urinary bladder, and non-muscle invasive bladder cancer (NMIBC). BCG is a vaccine-derived therapy that works by stimulating the immune system to attack cancer cells. It has been widely used and has a significant commercial presence. The drug has undergone numerous clinical trials and has been the subject of many publications. BCG's revenue is substantial, with $63.6 billion in revenue.
At a glance
| Generic name | bcg |
|---|---|
| Sponsor | Pfizer |
| Drug class | Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC] |
| Target | BCG targets the immune system, specifically the activation of immune cells such as T-cells and macrophages. |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Treatment of bladder cancer (superficial)
- Treatment of carcinoma in situ (CIS) of the urinary bladder
- Treatment of non-muscle invasive bladder cancer (NMIBC)
- Treatment of high-grade non-muscle invasive bladder cancer (NMIBC)
- Treatment of high-risk non-muscle invasive bladder cancer (NMIBC)
- Treatment of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)
- Treatment of non-muscle invasive bladder cancer (NMIBC) with high-grade tumor
- Treatment of non-muscle invasive bladder cancer (NMIBC) with high-risk tumor
- Treatment of superficial bladder cancer
- Treatment of superficial bladder cancer (stage Ta, T1)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade, high-risk)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade, high-risk, carcinoma in situ)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade, high-risk, carcinoma in situ, high-grade tumor)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade, high-risk, carcinoma in situ, high-grade tumor, high-risk tumor)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade, high-risk, carcinoma in situ, high-grade tumor, high-risk tumor, non-muscle invasive)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade, high-risk, carcinoma in situ, high-grade tumor, high-risk tumor, non-muscle invasive, non-muscle invasive bladder cancer)
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade, high-risk, carcinoma in situ, high-grade tumor, high-risk tumor, non-muscle invasive, non-muscle invasive bladder cancer, non-muscle invasive bladder cancer (NMIBC))
- Treatment of superficial bladder cancer (stage Ta, T1, Tis, high-grade, high-risk, carcinoma in situ, high-grade tumor, high-risk tumor, non-muscle invasive, non-muscle invasive bladder cancer, non-muscle invasive bladder cancer (NMIBC), non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ)
Boxed warnings
- WARNING TICE ® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of TICE ® BCG as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections). BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG (see WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS sections).
Common side effects
- Dysuria
- Arthritis/myalgia
- Urinary frequency
- Headache/dizziness
- Flu-like syndrome
- Urinary incontinence
- Hematuria
- Anorexia/weight loss
- Fever
- Urinary debris
- Malaise/fatigue
- Allergy
Drug interactions
- immunosuppressants and/or bone marrow depressants and/or radiation
- antimicrobial therapy
- antituberculosis drugs (e.g., isoniazid)
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (PHASE2)
- A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) (PHASE1, PHASE2)
- ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG (PHASE1, PHASE2)
- Early vs Delayed Intravesical Blad-Care During BCG Therapy (NA)
- A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (PHASE2)
- S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (PHASE3)
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tice Bcg CI brief — competitive landscape report
- Tice Bcg updates RSS · CI watch RSS
- Pfizer portfolio CI