Polatuzumab Vedotin

Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate with activity against dividing B cells. The small molecule, MMAE, is an anti-mitotic agent covalently attached to the antibody via a cleavable linker.

• 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. ( 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.ICD-10: C85.90

• None. None.contraindicated

The recommended dose of POLIVY is 1.8 mg/kg as an intravenous infusion every 21 days for 6 cycles. ( 2 ) Administer the initial POLIVY dose over 90 minutes. Subsequent infusions may be administered over 30 minutes if the previous infusion is tolerated. ( 2 ) Premedicate with an antihistamine and antipyretic before POLIVY. ( 2 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.4 ) 2.1 Recommended Dosage Patients with Previously Untreated DLBCL, NOS or HGBL The recommended dosage of POLIVY is 1.8 mg/kg administered as an intravenous infusion every 21 days for 6 cycles in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone [see Clinical Studies (14.1) ] . Administer POLIVY, cyclophosphamide, doxorubicin, and a rituximab product in any order on Day 1 after the administration of prednisone. Prednisone is administered on Days 1–5 of each cycle. Patients with Relapsed or Refractory DLBCL, NOS The recommended dosage of POLIVY is 1.8 mg/kg administered as an intravenous infusion every 21 days for 6 cycles in combination with bendamustine and a rituximab product. Administer POLIVY, bendamustine, and a rituximab product in any order on Day 1 of each cycle. The recommended dose of bendamustine is 90 mg/m 2 /day on Days 1 and 2 when administered with POLIVY and a rituximab product. The recommended dose of rituximab product is 375 mg/m 2 intravenously on Day 1 of each cycle. For All Indicated Patients If not already premedicated, administer an antihistamine and antipyretic at least 30 minutes prior to POLIVY.

Peripheral Neuropathy: Monitor patients for peripheral neuropathy and modify or discontinue dose accordingly. ( 5.1 ) Infusion-Related Reactions: Premedicate with an antihistamine and antipyretic. Monitor patients closely during infusions. Interrupt or discontinue infusion for reactions. ( 5.2 ) Myelosuppression: Monitor complete blood counts. Manage using dose delays or reductions and growth factor support. Monitor for signs of infection. ( 5.3 ) Serious and Opportunistic Infections: Closely monitor patients for signs of bacterial, fungal, or viral infections. ( 5.4 ) Progressive Multifocal Leukoencephalopathy (PML): Monitor patients for new or worsening neurological, cognitive, or behavioral changes suggestive of PML. ( 5.5 ) Tumor Lysis Syndrome: Closely monitor patients with high tumor burden or rapidly proliferative tumors. ( 5.6 ) Hepatotoxicity: Monitor liver enzymes and bilirubin. ( 5.7 ) Infusion Site Extravasation Injury: Ensure patent venous access prior to initiating the infusion and closely monitor the infusion site throughout administration for any signs of extravasation. Stop the infusion immediately if extravasation occurs. ( 5.8 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 3 months after the last dose. ( 5.9 ) 5.1 Peripheral Neuropathy POLIVY can cause peripheral neuropathy, including severe cases.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Peripheral Neuropathy [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Myelosuppression [see Warnings and Precautions (5.3) ] Serious and Opportunistic Infections [see Warnings and Precautions (5.4) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.5) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] Hepatotoxicity [see Warnings and Precautions (5.7) ] Infusion Site Extravasation Injury [see Warnings and Precautions (5.8) ] The most common adverse reactions (≥20%) in patients with large B-cell lymphoma treated with POLIVY in combination with R-CHP, excluding laboratory abnormalities, are peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. Grade 3 to 4 laboratory abnormalities (≥10%) are lymphopenia, neutropenia, hyperuricemia, and anemia. ( 6.1 ) The most common adverse reaction (≥20%) in patients with relapsed or refractory DLBCL treated with POLIVY in combination with BR are neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Hepatic impairment has the potential to increase exposure to MMAE. Monitor patients for adverse reactions. ( 8.6 ) Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , POLIVY can cause fetal harm. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of the small molecule component of POLIVY, MMAE, to pregnant rats during organogenesis at exposures below the clinical exposure at the recommended dose of 1.8 mg/kg POLIVY every 21 days resulted in embryo-fetal mortality and structural abnormalities (see Data ) . Advise a pregnant woman of the potential risks to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data No embryo-fetal development studies in animals have been performed with polatuzumab vedotin-piiq.

Metabolism

The exposure parameters of acMMAE and unconjugated MMAE (the cytotoxic component of polatuzumab vedotin-piiq) are summarized in Table 10 . The plasma exposure of acMMAE and unconjugated MMAE increased proportionally over a polatuzumab vedotin-piiq dose range from 0.1 to 2.4 mg/kg (0.06 to 1.33 times the approved recommended dosage).

• Jun 10, 2019BLABLA761121Genentech

1. 1Disease Progression1,97222%
2. 2Off Label Use1,26714%
3. 3Death7518.2%
4. 4Neutropenia5576.1%
5. 5Anaemia5275.8%
6. 6Covid-195215.7%
7. 7Febrile Neutropenia4865.3%
8. 8Drug Ineffective4765.2%
9. 9Pyrexia4745.2%
10. 10Blood Lactate Dehydrogenase Increased4164.6%
11. 11Platelet Count Decreased4144.5%
12. 12Neutrophil Count Decreased3914.3%
13. 13Cytokine Release Syndrome3894.3%
14. 14Thrombocytopenia3794.2%
15. 15White Blood Cell Count Decreased3754.1%

The 10 most recently updated of 96 ClinicalTrials.gov registrations naming Polatuzumab Vedotin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients
  Recruiting · Phase 2 · Interventional · 213 enrolled · Miltenyi Biomedicine GmbH
  NCT04844866updated 2026-06-10
• Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL)
  Completed · Phase 3 · Interventional · 306 enrolled · GWT-TUD GmbH
  NCT04833114updated 2026-06-10
• Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 40 enrolled · Ruijin Hospital
  NCT07638787updated 2026-06-10
• Testing Mosunetuzumab Alone, With Zanubrutinib, or With Polatuzumab Vedotin for Treating Marginal Zone Lymphoma That Came Back or Didn't Get Better With Treatment
  Not yet recruiting · Phase 2 · Interventional · 138 enrolled · SWOG Cancer Research Network
  NCT07638722updated 2026-06-10
• A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
  Recruiting · Phase 1 · Interventional · 200 enrolled · ADC Therapeutics S.A.
  NCT04970901updated 2026-06-09
• Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
  Recruiting · Phase 1 · Interventional · 224 enrolled · Celgene
  NCT04884035updated 2026-06-08
• A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)
  Recruiting · Phase 2 · Interventional · 594 enrolled · Merck Sharp & Dohme LLC
  NCT06890884updated 2026-06-08
• A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma
  Recruiting · Phase 2 · Interventional · 42 enrolled · Memorial Sloan Kettering Cancer Center
  NCT06765317updated 2026-06-05
• A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
  Recruiting · Phase 2 · Interventional · 496 enrolled · Genmab
  NCT05283720updated 2026-06-02
• Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
  Active not recruiting · Phase 1 · Interventional · 34 enrolled · National Cancer Institute (NCI)
  NCT04739813updated 2026-06-01

Frequently asked questions

How does Polatuzumab Vedotin work?

Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate with activity against dividing B cells. The small molecule, MMAE, is an anti-mitotic agent covalently attached to the antibody via a cleavable linker.

What is Polatuzumab Vedotin used for?

According to FDA labeling, Polatuzumab Vedotin carries indications including: 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. ( 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Polatuzumab Vedotin?

Polatuzumab Vedotin is classified as Other monoclonal antibodies and antibody drug conjugates, Antibody-Surface Protein Interactions, Cellular Proliferation Alteration, Increased Cellular Death.

What are the brand names for Polatuzumab Vedotin?

Polatuzumab Vedotin is marketed under brand names including Polivy.

What are the contraindications for Polatuzumab Vedotin?

Polatuzumab Vedotin labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.