Oncologic Drugs Advisory Committee - Benefit-Risk Profile of Genentech’s Polivy to Treat Untreated DLBCL

During tmeeting on 09 Mar 2023 the Oncologic Drugs Advisory Committee (ODAC) reviewe supplemental biologics license application for Polivy (polatuzumab vedotin-piiq) for injection, submitted by Genentech, Inc, for use in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

ODAC focused on efficacy concerns arising from the POLARIX study, but ultimately agreed with the sponsor because the trial met its primary efficacy endpoint and ODAC voiced near-unanimous support for the benefit-risk profile of Polivy.

Full meeting details available here.