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Oncovin (Vincristine Sulfate)
Vincristine Sulfate (Oncovin), marketed by Pfizer Inc., is a well-established chemotherapy agent primarily indicated for acute leukemia, with a key composition patent expiring in 2028. Its mechanism of action, which disrupts cell division by binding to tubulin, provides a strong therapeutic profile against its primary indication. The primary risk is the competition from off-patent generics of same-class drugs such as vinblastine and vinorelbine, which may erode market share.
At a glance
| Generic name | Vincristine Sulfate |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Vinca Alkaloid |
| Target | Canalicular multispecific organic anion transporter 1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1963 |
Approved indications
- Acute leukemia
- Hodgkin's disease
- Non-Hodgkin's malignant lymphomas
- Rhabdomyosarcoma
- Neuroblastoma
- Wilms' tumor
Boxed warnings
- WARNINGS Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. See OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection. WARNINGS This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. The intrathecal administration of Vincristine Sulfate Injection usually results in death. To reduce the potential for fatal medication errors due to incorrect route of administration, Vincristine Sulfate Injection should be diluted in a flexible plastic container and prominently labeled as indicated "FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES." See OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection.
Common side effects
- Febrile neutropenia
- Disease progression
- Febrile bone marrow aplasia
- Diffuse large B-cell lymphoma recurrent
- Haematotoxicity
- Mucosal inflammation
- Second primary malignancy
- Sepsis
- Pancytopenia
- Thrombocytopenia
- Acute myeloid leukaemia
- Hepatitis B reactivation
Drug interactions
- Phenytoin
- Itraconazole
- Fluconazole
- St. John's Wort
- P-glycoprotein (P-gp) inhibitors or inducers
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma (PHASE3)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Oncovin CI brief — competitive landscape report
- Oncovin updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI