Polivy FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 17, 2023.
FDA Approved: Yes (First approved June 10, 2019)
Brand name: Polivy
Generic name: polatuzumab vedotin-piiq
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Diffuse Large B-Cell Lymphoma
Polivy (polatuzumab vedotin-piiq) is a CD79b-directed antibody and microtubule inhibitor conjugate used for the treatment of diffuse large B-cell lymphoma.
- Polivy is 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.
- 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. - Diffuse large B-cell lymphoma (DLBCL) is an aggressive type of non-Hodgkin’s lymphoma (NHL).
- Polivy works by binding to the CD79b protein expressed specifically in the majority of B-cells, then destroys those targeted B-cells through the delivery of an anti-cancer agent.
- Polivy is administered via intravenous infusion over 90 minutes every 21 days for six cycles. Subsequent infusions may be administered over 30 minutes if the previous infusion is tolerated.
- Warnings and precautions associated with Polivy include peripheral neuropathy; infusion-related reactions; myelosuppression; serious and opportunistic bacterial, fungal, or viral infections; progressive multifocal leukoencephalopathy; tumor lysis syndrome; hepatotoxicity; and embryo-fetal toxicity.
- - The most common adverse reactions (≥20%) in patients with large B-cell lymphoma treated with Polivy in combination with R-CHP include peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. Grade 3 to 4 laboratory abnormalities (≥10%) include lymphopenia, neutropenia, hyperuricemia, and anemia.
- The most common adverse reactions (≥20%) in patients with relapsed or refractory DLBCL treated with Polivy in combination with bendamustine and rituximab include neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia. - The FDA granted full approval for Polivy on April 19, 2023. Accelerated approval was previously granted for relapsed or refractory DLBCL on June 10, 2019.
Development timeline for Polivy
Further information
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