OBR OncologyODAC Favors Upfront Polatuzumab Vedotin for LBCL

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to support the use of polatuzumab vedotin-piiq (Polivy) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola+R-CHP) for the first-line treatment of patients with previously untreated large B-cell lymphoma (LBCL). The committee voted 11-2 in favour of the drug following the confirmatory POLARIX trial, a double-blind, placebo-controlled, phase 3 study, which enrolled 879 patients with LBCL, including diffuse large B-cell lymphoma (DLBC), not otherwise specified (NOS). Although concerns were raised about modest benefits in progression-free survival (PFS) and similar overall survival (OS) between Pola+R-CHP and the standard treatment R-CHOP, ODAC member Neil Vasan, MD, PhD, said that the benefits outweighed the risks and Pola+R-CHP should be an option for first-time treatment of DLBCL with curative intent, as it could spare patients from more toxic and complicated salvage therapies.