Polivy泊洛妥珠单抗 polatuzumab vedotin

Drug Class

CD79b-directed antibody-drug conjugate

Mechanism

Binds to CD79b on B-cells, resulting in antibody-drug conjugate internalization and intracellular release of MMAE, which inhibits microtubule polymerization and induces cell apoptosis.

Approved Indication

Treatment of diffuse large B-cell lymphoma (DLBCL), in combination with R-CHP for previously untreated patients, or in combination with bendamustine and rituximab for relapsed/refractory disease.

What This Means For Patients

Polivy (polatuzumab vedotin) is an antibody-drug conjugate (ADC) designed to treat diffuse large B-cell lymphoma (DLBCL). It targets the CD79b protein on cancerous B-cells, delivering a powerful chemotherapy agent directly inside the cell. It is approved by the FDA, EMA, and NMPA.

Regulatory Approvals

• FDA — Approved (2019) — Sources
• EMA — Approved (2020) — Sources
• NMPA — Approved (2023) — Sources

Pivotal Clinical Evidence

• POLARIX — Tilly et al., N Engl J Med 2022 (NCT03274492) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761121s008lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/polivy
• https://www.nmpa.gov.cn/