POLIVY
Polivy (polatuzumab vedotin-piiq) is a CD79b-directed antibody-drug conjugate indicated for the treatment of specific aggressive B-cell lymphomas in adults. It is used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) in patients with an International Prognostic Index score of 2 or greater. The drug is also approved for use with bendamustine and a rituximab product for patients with relapsed or refractory DLBCL after at least two prior lines of therapy. These indications establish the drug's role in both frontline and salvage treatment settings for these hematologic malignancies.
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
- 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
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
ProIndications & Usage
FDA Label (PDF)POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. 1.1 Previou...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.