Quick answers
- What is Polatuzumab vedotin used for?
- The FDA-approved label (Polivy, Genentech, Inc., August 24, 2026) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Polatuzumab vedotin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Polatuzumab vedotin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Polatuzumab vedotin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Polatuzumab vedotin?
- 1 company lists prescription products of Polatuzumab vedotin in the FDA NDC Directory, including Genentech, Inc..
What Polatuzumab vedotin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Polivy, Genentech, Inc., effective August 24, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Polivy |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Genentech, Inc.2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761121 POLIVY | Genentech | June 10, 2019 | 3, latest March 18, 2026 2026: Labeling · 2023: Efficacy · 2020: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2174095, 2174100, 2398131, 2398133 |
|---|---|
| SPL set ID of the quoted label | 20a16ab2-f338-4abb-9dcd-254bd949a2bc |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761121 |
| Active ingredients (FDA) | POLATUZUMAB VEDOTIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Polivy, Genentech, Inc., effective August 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →