Overview
Polatuzumab vedotin is a CD79b-directed antibody-drug conjugate that delivers monomethyl auristatin E (MMAE), an anti-mitotic agent, to cancer cells. The drug consists of three components - a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b (polatuzumab), MMAE, and protease-cleavable linker called maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB) that covalently attaches MMAE to polatuzumab. Polatuzumab vedotin was granted accelerated FDA approval on June 10, 2019 and was approved by Health Canada on July 9, 2020.
Indication
Polatuzumab vedotin is used in combination with bendamustine and rituximab to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. In Canada, this indication is approved for patients who are not eligible for autologous stem cell transplant and have received at least one prior therapy. Polatuzumab vedotin is also used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) to treat adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high-grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.
Associated Conditions
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma
- High-grade B Cell Lymphoma (HGBCL)
- Large B Cell Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
- Relapsed Diffuse large B-cell lymphoma NOS
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 2 | Not yet recruiting | |||
2025/06/10 | Phase 2 | Not yet recruiting | Shanghai Zhongshan Hospital | ||
2025/03/24 | Phase 2 | Recruiting | |||
2025/01/31 | Phase 2 | Not yet recruiting | |||
2024/12/12 | Phase 1 | Recruiting | |||
2024/09/19 | Phase 2 | Not yet recruiting | |||
2024/08/15 | Phase 2 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/07/31 | Phase 2 | Recruiting | |||
2024/07/24 | Phase 2 | Not yet recruiting | |||
2024/06/21 | Phase 2 | ENROLLING_BY_INVITATION | The First Affiliated Hospital of Soochow University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genentech, Inc. | 50242-105 | INTRAVENOUS | 140 mg in 7.52 mL | 4/2/2024 | |
| Genentech, Inc. | 50242-103 | INTRAVENOUS | 30 mg in 1.88 mL | 4/2/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/16/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| POLIVY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30MG | SIN16345P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 30mg/vial | 10/5/2021 | |
| POLIVY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 140MG | SIN16007P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 140 mg | 9/8/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Polatuzumab Vedotin for Injection | 国药准字SJ20230004 | 生物制品 | 注射剂 | 1/10/2023 | |
| Polatuzumab Vedotin for Injection | 国药准字SJ20230003 | 生物制品 | 注射剂 | 1/10/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| POLIVY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 140MG | N/A | N/A | N/A | 5/13/2020 | |
| POLIVY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30MG | N/A | N/A | N/A | 6/22/2021 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| POLIVY polatuzumab vedotin 140 mg powder for injection vial | 314866 | Medicine | A | 10/21/2019 | |
| POLIVY polatuzumab vedotin 30 mg powder for injection vial | 374135 | Medicine | A | 8/10/2022 |
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