AVZIVI (bevacizumab-tnjn) · BIO-THERA SOLUTIONS LTD
Avzivi is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracilbased chemotherapy for first- or second-line treatment. Metastatic colorectal cancer, in combination with fluoropyrimidine irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
Details
- Status
- Prescription
- First Approved
- 2023-12-06
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AVZIVI Approval History
What AVZIVI Treats
8 indicationsAVZIVI is approved for 8 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Colorectal Cancer
- Non-Small Cell Lung Cancer
- Glioblastoma
- Renal Cell Carcinoma
- Cervical Cancer
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
AVZIVI is a lower-cost alternative to Avastin with no clinically meaningful differences. Requires prescriber approval to substitute.
AVZIVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AVZIVI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AVZIVI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AVZIVI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AVZIVI FDA Label Details
Indications & Usage
FDA Label (PDF)Avzivi is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracilbased chemotherapy for first- or second-line treatment. Metastatic colorectal cancer, in combination with fluoropyrimidine irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use : Avzivi is not indicated for adjuvant treatment of colon cancer. Unresectable, locally advanced, recurrent or metas...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.