BLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
GAZYVA (obinutuzumab) by Roche is cd20-directed antibody interactions [moa]. Approved for cd20-directed cytolytic antibody [epc]. First approved in 2013.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GAZYVA (obinutuzumab) is a CD20-directed monoclonal antibody approved in 2013 for treating B-cell malignancies and autoimmune conditions. It binds to CD20 on B cells and triggers cytolytic destruction through antibody-dependent cellular cytotoxicity and direct apoptosis. The drug is administered as an intravenous injection.
$6MPart D
PeakAt peak lifecycle stage with modest Part D spending, indicating mature but limited Medicare penetration; brand team likely focused on specialty segment optimization rather than expansion.
Mechanism of Action
CD20-directed Antibody Interactions
Pharmacologic Class:
CD20-directed Cytolytic Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
Started Jan 2026
80 enrolled
Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study
Started Oct 2025
20 enrolled
Membranous Nephropathy - PLA2R Induced
Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Started Jul 2025
40 enrolled
Chronic Lymphocytic LeukemiaSmall Lymphocytic Leukemia (SLL)
A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
Started Jun 2025
630 enrolled
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This
Started Jun 2025
34 enrolled
Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaSmall Lymphocytic LymphomaCLL/SLL+1 more
Worked on GAZYVA at Roche? Share your interview experience or compensation data (+7 days Pro)
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.