GAZYVA
PeakmAbBLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
7/8 — Comprehensive
Priority Review
GAZYVA by Roche is cd20 antigen expressed on the surface of pre-b and mature b lymphocytes. Approved for a rituximab-containing regimen, iv follicular lymphoma, relapse in adult and 2 more indications. First approved in 2013.
Drug data last refreshed 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GAZYVA (obinutuzumab) is a CD20-directed cytolytic monoclonal antibody administered by injection for B-cell malignancies and autoimmune conditions. It works by binding to CD20 antigen on B cells, triggering direct cell death and immune-mediated cytotoxicity. The drug targets patients with conditions requiring B-cell depletion, including chronic lymphocytic leukemia and certain lymphomas.
$6MPart D
PeakStable
Product is in peak commercial phase with established market presence; commercial team size is likely stable with focus on market defense against competing CD20 agents.
Mechanism of Action
CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, obinutuzumab mediates B-cell lysis through (1) engagement of immune effector cells, (2) by directly activating intracellular death signaling pathways (direct cell death), and/or (3) activation of the…
Indications (5)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.