POLIVY (polatuzumab vedotin-piiq)
POLIVY is indicated for the treatment of Previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), in adults with an International Prognostic Index score of 2 or greater; Previously untreated high-grade B-cell lymphoma (HGBL) in adults with an International Prognostic Index score of 2 or greater; Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), in adults.
How POLIVY Works
Polatuzumab vedotin-piiq is an antibody-drug conjugate that targets CD79b, a protein component of the B-cell receptor. The monoclonal antibody binds to CD79b on the surface of B cells, causing the drug to be internalized and processed by lysosomal proteases. This release of the small molecule MMAE, an anti-mitotic agent, allows it to bind to microtubules and inhibit cell division. The resulting disruption of the microtubule network induces apoptosis in the dividing B cells.
Details
- Status
- Prescription
- First Approved
- 2019-06-10
- Patent Cliff
- 2030
- Revenue
- $435M (Q4-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
POLIVY Approval History
What POLIVY Treats
3 indicationsPOLIVY is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), in adults with an International Prognostic Index score of 2 or greater
- Previously untreated high-grade B-cell lymphoma (HGBL) in adults with an International Prognostic Index score of 2 or greater
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), in adults
POLIVY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 POLIVY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications POLIVY treats. First-in-class if their pivotal trials read out positive.
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.
POLIVY FDA Label Details
Indications & Usage
FDA Label (PDF)POLIVY is indicated for the treatment of Previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), in adults with an International Prognostic Index score of 2 or greater; Previously untreated high-grade B-cell lymphoma (HGBL) in adults with an International Prognostic Index score of 2 or greater; Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), in adults.
Pro Intelligence Preview
Deep insights for POLIVY
Revenue Insights
- • Q4-2025: $435M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.