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Polivy (POLATUZUMAB VEDOTIN)
Polivy works by binding to a protein on the surface of cancer cells and releasing a toxin that kills the cell.
Polivy (Polatuzumab Vedotin) is a small molecule modality developed by Genentech, targeting the B-cell antigen receptor complex-associated protein beta chain. It was approved by the FDA in 2019 for the treatment of diffuse large B-cell lymphoma that is refractory. Polivy works by binding to the target protein and releasing a cytotoxic agent, causing cell death. The commercial status of Polivy is patented, and it is currently owned by Genentech. Key safety considerations include its potential for severe neutropenia and thrombocytopenia.
At a glance
| Generic name | POLATUZUMAB VEDOTIN |
|---|---|
| Sponsor | Roche |
| Target | B-cell antigen receptor complex-associated protein beta chain |
| Modality | Antibody drug conjugate |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 1600 |
Mechanism of action
Polatuzumab vedotin-piiq is CD79b-directed antibody-drug conjugate with activity against dividing cells. The small molecule, MMAE, is an anti-mitotic agent covalently attached to the antibody via cleavable linker. The monoclonal antibody binds to CD79b, B-cell specific surface protein, which is component of the B-cell receptor. Upon binding CD79b, polatuzumab vedotin-piiq is internalized, and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.
Approved indications
- Diffuse large B-cell lymphoma refractory
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Peripheral neuropathy
- Fatigue
- Diarrhea
- Pyrexia
- Decreased appetite
- Pneumonia
- Sepsis
- Dizziness
- Vomiting
Key clinical trials
- Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (PHASE1)
- Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation (PHASE2)
- 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) (PHASE2)
- An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma (PHASE3)
- A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL (PHASE2)
- 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) (PHASE1)
- A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma (PHASE3)
- A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Polivy CI brief — competitive landscape report
- Polivy updates RSS · CI watch RSS
- Roche portfolio CI