FDA approved Polivy combo for untreated large B-cell lymphoma in April 2023
The agency cleared polatuzumab vedotin-piiq with R-CHP for adult patients with previously untreated diffuse large B-cell lymphoma and high-grade B-cell lymphoma.
The Food and Drug Administration approved polatuzumab vedotin-piiq, marketed as Polivy by Genentech, Inc., on April 19, 2023. The approval covers use of the drug with a rituximab product, cyclophosphamide, doxorubicin, and prednisone, known as R-CHP, for adult patients with previously untreated diffuse large B-cell lymphoma, not otherwise specified.1
The approval also extends to adult patients with previously untreated high-grade B-cell lymphoma, according to the FDA's announcement.
This action adds a frontline indication for polatuzumab vedotin-piiq in combination with the R-CHP regimen, as stated in the FDA's approval notice. The document provided does not include additional details on trial endpoints, dosing schedules, or further regulatory steps beyond confirming the April 19, 2023 approval date and the specific patient populations named above.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.