FDA ODAC Gives Green Light to First-Line Polatuzumab Vedotin-Piiq Plus R-CHP in DLBCL

By Leah Sherwood - Last Updated: March 10, 2023

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to two in favor of the clinical benefit of polatuzumab vedotin-piiq in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Polatuzumab vedotin-piiq is a first-in-class anti-CD79b antibody-drug conjugate. It binds to the CD79b protein found on the surface of cancerous B cells and destroys them through the delivery of an anticancer agent.

The FDA is expected to make a final decision on its review of the supplemental Biologics License Application (sBLA) for polatuzumab vedotin-piiq for treatment of DLBCL by April 2, 2023.

The sBLA is based on data from the phase III POLARIX trial, which showed the combination of polatuzumab vedotin-piiq and R-CHP improved progression-free survival compared to standard-of-care R-CHOP chemotherapy. Specifically, the risk of disease progression, relapse, or death was reduced by 27% with polatuzumab vedotin-piiq plus R-CHP when compared with R-CHOP (hazard ratio [HR], 0.73; 95% CI, 0.57–0.95; P<.02).

Safety outcomes were consistent with previous trials, and the safety profile was comparable for polatuzumab vedotin-piiq plus R-CHP versus R-CHOP, including in the rates of grade 3-4 adverse events (AEs; 57.7% vs 57.5%), serious AEs (34.0% vs 30.6%), grade 5 AEs (3.0% vs 2.3%), and AEs leading to dose reduction (9.2% vs 13.0%).

Source: Genentech, March 2023

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