Polivy (Polatuzumab Vedotin)
Antibody-drug conjugate for the treatment of diffuse large B-cell lymphoma (DLBCL)
Polivy (polatuzumab vedotin) is a targeted antibody-drug conjugate used to treat diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive non-Hodgkin lymphoma. It works by delivering a potent cell-killing agent directly to cancerous B-cells. Polivy is always administered in combination with other chemotherapy medicines and is given as an intravenous infusion in a hospital setting under specialist supervision.
Quick Facts
Key Takeaways
- Polivy is an antibody-drug conjugate that targets CD79b on B-cell lymphoma cells, delivering the cytotoxic agent MMAE directly to cancer cells.
- It is approved for both previously untreated DLBCL (with R-CHP) and relapsed/refractory DLBCL (with bendamustine and rituximab) in patients ineligible for stem cell transplant.
- The standard dose is 1.8 mg/kg given as a 90-minute intravenous infusion on day 1 of each 21-day cycle for 6 cycles.
- Common side effects include peripheral neuropathy, low blood counts (neutropenia, anemia, thrombocytopenia), infections, fatigue, and gastrointestinal symptoms.
- Regular blood tests are essential during treatment to monitor blood cell counts and liver function; dose adjustments may be required for peripheral neuropathy.
What Is Polivy and What Is It Used For?
Polivy contains the active substance polatuzumab vedotin, a sophisticated antibody-drug conjugate (ADC) that combines the targeting ability of a monoclonal antibody with the cell-killing power of a cytotoxic chemotherapy agent. This dual mechanism allows Polivy to selectively seek out and destroy cancerous B-cells while potentially sparing healthy tissue from the worst effects of conventional chemotherapy.
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma worldwide, accounting for approximately 30–40% of all newly diagnosed cases. It is an aggressive (fast-growing) cancer that develops from B-lymphocytes — a type of white blood cell that normally plays an important role in the immune system by producing antibodies to fight infections. In DLBCL, these B-cells grow uncontrollably and can form tumors in lymph nodes, the spleen, bone marrow, or other organs throughout the body.
How Does Polivy Work?
Polivy works through a highly targeted mechanism of action. The medicine consists of two key components: a monoclonal antibody that recognizes and binds to a protein called CD79b found on the surface of B-cells, and a potent cytotoxic agent called MMAE (monomethyl auristatin E) that is chemically linked to the antibody.
When Polivy is administered intravenously, the monoclonal antibody component circulates through the bloodstream and seeks out B-cells expressing CD79b on their surface. Once the antibody attaches to CD79b, the entire ADC complex is internalized (taken up) by the cancer cell. Inside the cell, the chemical linker is broken down, releasing MMAE directly into the cancer cell. MMAE then disrupts the cell’s microtubule network — a critical structure needed for cell division — causing the cancer cell to stop dividing and ultimately die through a process called apoptosis (programmed cell death).
This targeted delivery system is a significant advancement over conventional chemotherapy because it concentrates the cytotoxic payload precisely where it is needed most, at the site of the cancer cell. Although some healthy B-cells also express CD79b and may be affected, the selectivity of this approach can result in a more favorable balance between anti-cancer efficacy and side effects compared to untargeted chemotherapy agents.
Approved Indications
Polivy has been approved by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other regulatory authorities worldwide for two distinct clinical settings:
- Previously untreated DLBCL: Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (known as Pola-R-CHP) for adults with previously untreated diffuse large B-cell lymphoma. This approval was supported by the pivotal POLARIX clinical trial.
- Relapsed or refractory DLBCL: Polivy in combination with bendamustine and rituximab (Pola-BR) for adults with relapsed or refractory DLBCL who have received at least one prior therapy and are not candidates for hematopoietic stem cell transplantation.
Polivy is never used as a single agent (monotherapy). It is always administered as part of a combination chemotherapy regimen, where it replaces or supplements specific components to enhance the overall anti-cancer effectiveness of the treatment protocol.
What Should You Know Before Taking Polivy?
Before initiating treatment with Polivy, your healthcare team will conduct a comprehensive assessment to determine whether this medicine is appropriate and safe for you. It is essential to share your complete medical history, including all current and past medical conditions, all medications you are taking, and any known allergies. This information helps your oncologist tailor the treatment plan to your individual circumstances and minimize the risk of serious complications.
Contraindications
Polivy must not be used in the following situations:
- Hypersensitivity: If you are allergic to polatuzumab vedotin or to any of the excipients (inactive ingredients) contained in the formulation, including sucrose, succinic acid, sodium hydroxide, or polysorbate 20.
- Active severe infection: If you currently have a severe active infection, treatment with Polivy must not be started until the infection has been adequately treated and resolved.
If either of these conditions applies to you, inform your doctor immediately. Treatment with Polivy should not be initiated, and alternative treatment options will be discussed.
Warnings and Precautions
Talk to your doctor or nurse before starting Polivy if any of the following apply to you:
Contact your healthcare team immediately if you experience: signs of infection (fever, chills, cough), unusual bleeding or bruising, numbness or tingling in hands or feet, memory loss or difficulty speaking, yellowing of the skin or eyes (jaundice), or difficulty breathing.
Peripheral neuropathy: Polivy can cause damage to the peripheral nerves, resulting in symptoms such as numbness, tingling, burning sensations, pain, weakness, or difficulty walking, particularly in the hands and feet. If you already have existing nerve damage or neurological problems, inform your doctor before treatment begins, as Polivy may worsen these symptoms. Your doctor will monitor you closely and may need to reduce your dose or delay treatment if neuropathy develops or worsens.
Myelosuppression: Polivy can significantly reduce the production of blood cells in the bone marrow, leading to low levels of white blood cells (increasing infection risk), red blood cells (causing anemia and fatigue), and platelets (increasing bleeding risk). Regular blood tests will be performed throughout your treatment to monitor these counts. You should report any symptoms such as fever, persistent fatigue, dizziness, unusual bleeding, or bruising to your healthcare team immediately.
Infections: Because Polivy suppresses the immune system, you are at increased risk of developing infections, some of which can be serious or life-threatening. These include bacterial infections, viral infections (including herpes reactivation), pneumonia, and urinary tract infections. Tell your doctor if you have a history of recurrent or chronic infections before starting treatment.
Progressive multifocal leukoencephalopathy (PML): PML is an extremely rare but potentially fatal brain infection that has been reported in a patient treated with Polivy in combination with bendamustine and obinutuzumab. Symptoms include memory loss, speech difficulties, problems walking, and vision changes. If you experience any of these neurological symptoms, contact your doctor immediately as urgent medical evaluation is required.
Tumor lysis syndrome (TLS): Rapid destruction of cancer cells during treatment can release large amounts of cellular contents into the bloodstream, leading to dangerous imbalances in potassium, uric acid, phosphate, and calcium levels. Your doctor will perform blood tests to monitor for this condition, particularly during the first cycles of treatment.
Infusion-related reactions: Allergic or infusion-related reactions can occur during or shortly after the Polivy infusion. Symptoms may include fever, chills, rash, hives, breathing difficulties, or low blood pressure. You will be monitored for 30 to 90 minutes after each infusion. If a severe reaction occurs, your doctor may slow or stop the infusion and may discontinue Polivy treatment altogether.
Hepatotoxicity: Polivy can cause liver damage, including elevated liver enzymes and bilirubin levels. Most cases are asymptomatic and detected only through routine blood tests, but in some cases jaundice (yellowing of the skin and eyes) may develop. Liver function tests will be performed before and regularly during treatment.
Pregnancy and Breastfeeding
Polivy may cause harm to an unborn child based on its mechanism of action and findings from animal studies. It is critically important to discuss pregnancy planning with your doctor before starting treatment.
- Women of childbearing potential: Must use effective contraception during Polivy treatment and for at least 9 months after the last dose.
- Men: Must use effective contraception during treatment and for at least 6 months after the last dose. Men should consider sperm banking before starting treatment, as Polivy may impair fertility.
- Pregnancy: Do not use Polivy if you are pregnant unless your doctor determines the benefit clearly outweighs the risk. Inform your doctor immediately if you become pregnant during treatment.
- Breastfeeding: Do not breastfeed during treatment with Polivy and for at least 3 months after the last dose, as the medicine may pass into breast milk.
Children and Adolescents
Polivy is not approved for use in children and adolescents under 18 years of age. There are no clinical data on the safety and efficacy of Polivy in this age group, and it should not be administered to pediatric patients.
Driving and Operating Machinery
Polivy may have a minor effect on your ability to drive or operate machinery. If you experience infusion-related reactions, peripheral neuropathy, fatigue, dizziness, or weakness during treatment, you should not drive, cycle, or operate tools or machinery until these symptoms have resolved.
How Does Polivy Interact with Other Drugs?
Because Polivy is an antibody-drug conjugate that releases MMAE (a potent cytotoxic agent) inside target cells, understanding potential drug interactions is important for safe treatment. While no formal pharmacokinetic drug interaction studies have been conducted specifically for Polivy, the MMAE component is known to be a substrate of CYP3A4 and P-glycoprotein (P-gp), which means that medicines affecting these pathways could theoretically alter MMAE levels in the body.
Always inform your doctor and healthcare team about all medicines you are currently taking, have recently taken, or might take. This includes prescription medicines, over-the-counter drugs, vitamins, dietary supplements, and herbal products.
Combination Therapy Partners
Polivy is specifically designed to be used in combination with the following chemotherapy regimens:
| Regimen | Combination Drugs | Indication |
|---|---|---|
| Pola-R-CHP | Rituximab, cyclophosphamide, doxorubicin, prednisone | Previously untreated DLBCL |
| Pola-BR | Bendamustine, rituximab | Relapsed/refractory DLBCL (after ≥1 prior therapy, not eligible for stem cell transplant) |
Vaccines
Live or live-attenuated vaccines should not be administered during treatment with Polivy, as the immunosuppressive effects of the treatment may increase the risk of infection from the vaccine. If you are planning to have any vaccinations or if you know you may need a vaccine in the near future, discuss this with your doctor before starting Polivy treatment. Inactivated vaccines may be administered during treatment, but the immune response may be diminished.
Potential Pharmacological Interactions
| Drug Category | Examples | Interaction Type | Clinical Significance |
|---|---|---|---|
| Strong CYP3A4 inhibitors | Ketoconazole, itraconazole, ritonavir, clarithromycin | May increase MMAE exposure | Monitor for increased toxicity |
| Strong CYP3A4 inducers | Rifampicin, carbamazepine, phenytoin, St. John’s wort | May decrease MMAE exposure | Potential reduced efficacy |
| P-glycoprotein inhibitors | Cyclosporine, verapamil, quinidine | May increase MMAE exposure | Use with caution |
| Live vaccines | MMR, varicella, BCG, yellow fever | Increased risk of vaccine-related infection | Contraindicated during treatment |
Polivy contains polysorbate 20 (1.8 mg per 30 mg vial; 8.4 mg per 140 mg vial). Polysorbates can cause allergic reactions in sensitive individuals. Inform your doctor if you have any known allergies to polysorbates.
What Is the Correct Dosage of Polivy?
Polivy is always administered under the supervision of a physician experienced in the use of anti-cancer therapies, in a hospital or outpatient clinic setting equipped to manage potential infusion reactions. Your dose is individually calculated based on your body weight, and your healthcare team will prepare and administer the infusion for you.
Adults
Standard Adult Dosage
- Dose: 1.8 mg per kilogram of body weight
- Route: Intravenous (IV) infusion
- Infusion duration: 90 minutes (first infusion); may be reduced to 30 minutes for subsequent infusions if well tolerated
- Frequency: Day 1 of each 21-day cycle
- Total treatment: 6 cycles
| Setting | Regimen | Polivy Dose | Cycle Length | Number of Cycles |
|---|---|---|---|---|
| Previously untreated DLBCL | Pola-R-CHP | 1.8 mg/kg IV | 21 days | 6 |
| Relapsed/refractory DLBCL | Pola-BR | 1.8 mg/kg IV | 21 days | 6 |
Dose Adjustments
Your doctor may need to adjust your Polivy dose based on how you respond to treatment and any side effects you experience. The most common reason for dose reduction is the development of peripheral neuropathy (nerve damage).
| Neuropathy Grade | Symptoms | Action |
|---|---|---|
| Grade 1 | Mild symptoms (numbness, tingling) not interfering with daily activities | Continue Polivy at current dose; monitor closely |
| Grade 2 (new or worsening) | Moderate symptoms limiting some daily activities | Reduce Polivy dose to 1.4 mg/kg |
| Grade 3–4 | Severe symptoms preventing daily activities or life-threatening | Discontinue Polivy permanently |
Children
Polivy is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of Polivy have not been established in the pediatric population, and no dosing recommendations are available for this age group.
Elderly
No specific dose adjustment is recommended for elderly patients based on age alone. However, elderly patients may be more susceptible to certain side effects, particularly infections and peripheral neuropathy, and should be monitored more closely during treatment. Clinical trial data included patients up to the age of 80 years, and the safety profile was generally consistent across age groups.
Missed Dose
If you miss a scheduled Polivy infusion appointment, contact your healthcare team as soon as possible to arrange a new appointment. It is very important not to miss doses in order for the treatment to achieve its full therapeutic effect. Your doctor will advise on the best timing for the rescheduled infusion to maintain the treatment schedule as closely as possible.
Overdose
There is no specific antidote for Polivy overdose. If an overdose occurs, the patient should be closely monitored for signs and symptoms of adverse reactions, and appropriate supportive measures should be initiated promptly. Since Polivy is administered in a supervised clinical setting, the risk of accidental overdose is very low.
Discontinuing Polivy treatment without discussing it with your oncologist could allow your cancer to progress. If you are experiencing side effects that concern you, talk to your healthcare team about possible dose adjustments or supportive care measures rather than stopping treatment on your own.
What Are the Side Effects of Polivy?
As with all medicines, Polivy can cause side effects, although not everybody gets them. Some side effects can be serious and may require immediate medical attention. Your healthcare team will monitor you closely throughout treatment and can provide supportive care to help manage many of these side effects. It is important to report any new or worsening symptoms promptly so that appropriate action can be taken.
Contact your doctor or nurse immediately if you experience any of the following: fever and chills (signs of infection), unusual bleeding or bruising, severe numbness or weakness in hands/feet, memory loss or speech difficulties, yellowing of skin or eyes (jaundice), difficulty breathing, or severe allergic reactions during infusion (rash, swelling, low blood pressure).
Side Effect Frequency Overview
Very Common
- Peripheral neuropathy (numbness, tingling, burning, pain, weakness in hands/feet, difficulty walking)
- Low neutrophil count (neutropenia) with or without fever
- Low red blood cell count (anemia)
- Low platelet count (thrombocytopenia)
- Low levels of all white blood cells
- Pneumonia (lung infection)
- Upper respiratory tract infection (runny nose, sneezing, sore throat, cough)
- Fever
- Cough
- Nausea
- Diarrhea or constipation
- Vomiting
- Abdominal pain
- Mouth and gut inflammation (mucositis)
- Fatigue
- Decreased appetite and weight loss
- Hair loss (alopecia)
- Low potassium levels (hypokalemia)
- Infusion-related reactions
- Common cold
Common
- Severe infection (sepsis)
- Urinary tract infection
- Viral infections
- Herpes infection
- Skin infection
- Shortness of breath and difficulty breathing
- Dizziness
- Fluid retention causing swelling (peripheral edema)
- Elevated liver enzymes (transaminases)
- Joint pain (arthralgia)
- Muscle pain (myalgia)
- Itching (pruritus)
- Chills
- Skin rash
- Dry skin
- Low lymphocyte count (lymphopenia)
- Decreased blood cell counts of all types (pancytopenia)
- Low phosphate levels (hypophosphatemia)
- Low calcium levels (hypocalcemia)
- Low albumin levels (hypoalbuminemia)
- Elevated lipase levels
Uncommon
- Blurred vision
Rare / Very Rare
- Progressive multifocal leukoencephalopathy (PML) — a very rare, life-threatening brain infection
Managing Side Effects
Many side effects of Polivy can be managed with supportive care. Your oncology team can prescribe anti-nausea medications, antibiotics to prevent or treat infections, and growth factor injections to boost blood cell production if needed. If peripheral neuropathy develops, your doctor may adjust your Polivy dose to help prevent progression. It is essential to attend all scheduled blood tests and follow-up appointments so that your healthcare team can detect and address side effects early.
If you experience any side effects not listed here, or if a listed side effect worsens significantly, report it to your doctor or nurse. Reporting suspected side effects to your national medicines regulatory authority helps ensure continuous monitoring of the benefit-risk balance of medicines.
How Should You Store Polivy?
Polivy is a hospital-administered medicine that is stored, prepared, and handled by trained healthcare professionals. Patients do not need to store or handle Polivy at home. However, the following storage information is provided for completeness and for the reference of healthcare providers:
- Unopened vials: Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep the vial in the original outer carton to protect from light. Do not freeze.
- Reconstituted solution: Should be used immediately. If not used immediately, the reconstituted solution may be stored for up to 72 hours refrigerated (2°C–8°C) or up to 24 hours at room temperature (9°C–25°C), provided reconstitution occurred under appropriate aseptic conditions.
- Diluted infusion solution: Stability depends on the diluent used:
- 0.9% sodium chloride: Up to 72 hours refrigerated or up to 4 hours at room temperature
- 0.45% sodium chloride: Up to 72 hours refrigerated or up to 8 hours at room temperature
- 5% glucose: Up to 72 hours refrigerated or up to 8 hours at room temperature
- Expiry: Do not use after the expiration date printed on the vial label and outer carton (EXP). The expiration date refers to the last day of the stated month.
Keep all medicines out of the sight and reach of children. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures help protect the environment.
What Does Polivy Contain?
Polivy is supplied as a white to slightly greyish-white lyophilized (freeze-dried) powder cake in a single-use glass vial. It must be reconstituted with sterile water for injection before further dilution and administration.
| Component | 30 mg Vial | 140 mg Vial |
|---|---|---|
| Active substance | Polatuzumab vedotin 30 mg | Polatuzumab vedotin 140 mg |
| Reconstitution volume | 1.8 ml sterile water | 7.2 ml sterile water |
| Concentration after reconstitution | 20 mg/ml | 20 mg/ml |
| Polysorbate 20 content | 1.8 mg | 8.4 mg |
Inactive ingredients (excipients): Succinic acid, sodium hydroxide, sucrose, and polysorbate 20. The finished product contains less than 1 mmol (23 mg) sodium per dose, making it essentially sodium-free.
Packaging: Each carton contains one single-use glass vial. Polivy is manufactured by Roche Registration GmbH, Grenzach-Wyhlen, Germany.
Frequently Asked Questions About Polivy
Polivy (polatuzumab vedotin) is used to treat diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive non-Hodgkin lymphoma. It is approved for previously untreated DLBCL in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP), and for relapsed or refractory DLBCL in combination with bendamustine and rituximab (Pola-BR) in patients who are not eligible for stem cell transplant.
Polivy is given as an intravenous (IV) infusion in a hospital or clinic setting, always under the supervision of an experienced oncologist. The first infusion is administered over 90 minutes. If well tolerated, subsequent infusions may be given over 30 minutes. The dose is 1.8 mg per kilogram of body weight, given on day 1 of each 21-day cycle for a total of 6 cycles.
The most serious side effects include severe infections (including sepsis and pneumonia), progressive multifocal leukoencephalopathy (PML, a rare fatal brain infection), severe myelosuppression (very low blood cell counts), tumor lysis syndrome, severe infusion-related reactions, and hepatotoxicity (liver damage). These require immediate medical attention and may necessitate treatment discontinuation.
Polivy should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Based on its mechanism of action, Polivy is expected to cause fetal harm. Women of childbearing potential must use effective contraception during treatment and for at least 9 months after the last dose. Men must use contraception during treatment and for 6 months afterward. Men should consider sperm banking before starting treatment.
In the standard R-CHOP regimen, vincristine is one of the chemotherapy components. In the Pola-R-CHP regimen, Polivy replaces vincristine. Unlike vincristine, which is a non-targeted cytotoxic drug, Polivy is an antibody-drug conjugate that specifically targets the CD79b protein on B-cell lymphoma cells. In the POLARIX clinical trial, Pola-R-CHP demonstrated superior progression-free survival compared to R-CHOP in patients with previously untreated DLBCL.
Polivy is stored and handled by healthcare professionals. Unopened vials are kept refrigerated at 2°C to 8°C in the original carton to protect from light. The medicine must not be frozen. After reconstitution, the solution can be stored for up to 72 hours refrigerated or up to 24 hours at room temperature. The diluted infusion solution stability varies by diluent (4–8 hours at room temperature or 72 hours refrigerated).
References & Sources
- European Medicines Agency (EMA). Polivy (polatuzumab vedotin) — Summary of Product Characteristics. Last updated 2025. Available at: EMA — Polivy EPAR
- U.S. Food and Drug Administration (FDA). POLIVY (polatuzumab vedotin-piiq) — Prescribing Information. Genentech, Inc. Available at: FDA Label
- Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma. N Engl J Med. 2022;386(4):351–363. doi:10.1056/NEJMoa2115304 (POLARIX trial)
- Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol. 2020;38(2):155–165. doi:10.1200/JCO.19.00172
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 2.2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: World Health Organization.
- British National Formulary (BNF). Polatuzumab vedotin. NICE Evidence Services. Available at: BNF
- Deeks ED. Polatuzumab vedotin: First global approval. Drugs. 2019;79(13):1467–1475. doi:10.1007/s40265-019-01175-0
Medical Editorial Team
This article was written by the iMedic Medical Editorial Team, which includes specialists in oncology, hematology, and clinical pharmacology. All content is reviewed according to international guidelines from the EMA, FDA, NCCN, and WHO.
Our editorial process follows the GRADE evidence framework and requires Level 1A evidence (systematic reviews and meta-analyses of randomized controlled trials) for all clinical claims. No pharmaceutical company sponsorship or commercial funding influences our content.
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