Prescription medicine
Polatuzumab vedotin Brand names: Polivy
Polatuzumab vedotin (Polivy) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the polatuzumab vedotin FDA label on DailyMed (effective August 24, 2026); every polatuzumab vedotin label on DailyMed.
Highlights of the record
FDA label of August 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePOLIVY 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.
Forms and strengths
- 30 mg/1.88ml
- 140 mg/7.52ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9,702 through July 30, 2026
What is polatuzumab vedotin used for?
From the label: indications and usagePOLIVY 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. ( 1.1 ) 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. […]
Source: FDA drug label (POLIVY), Genentech, Inc., effective August 24, 2026 (SPL set 20a16ab2-f338-4abb-9dcd-254bd949a2bc), via openFDA; the full label on DailyMed
Is there a generic for polatuzumab vedotin (Polivy)?
No generic polatuzumab vedotin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the polatuzumab vedotin label say about other medicines?
The polatuzumab vedotin label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bendamustine | warnings and precautions | Consider prophylactic G-CSF administration in patients receiving POLIVY plus bendamustine and a rituximab product. |
| Obinutuzumab | warnings and precautions | Leukoencephalopathy (PML) PML has been reported after treatment with POLIVY plus bendamustine and obinutuzumab in study GO29365 (0.6%, 1/173). |
| Rituximab | warnings and precautions | Consider prophylactic G-CSF administration in patients receiving POLIVY plus bendamustine and a rituximab product. |
Source: FDA drug label (POLIVY), Genentech, Inc., effective August 24, 2026 (SPL set 20a16ab2-f338-4abb-9dcd-254bd949a2bc), via openFDA; the full label on DailyMed
What do FAERS reports show for polatuzumab vedotin?
The FDA Adverse Event Reporting System holds 9,702 reports that list polatuzumab vedotin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,075 are coded as a death and 2,557 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (2,266, against a median of 467 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Polatuzumab vedotin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other