FDA approves polatuzumab vedotin plus R-CHP for patients with previously untreated DLBCL

On April 19, 2023, the U.S. Food and Drug Administration (FDA) approved the use of polatuzumab vedotin with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola + R-CHP) for adults with 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 (IPI) score of two or greater.1

Polatuzumab vedotin is a novel antibody-drug conjugate (ADC) targeting CD79b that delivers monomethyl auristatin E (MMAE), a microtubule inhibitor, to kill cancer cells.2,3 CD79b is involved in the B-cell receptor signaling pathway, and is expressed on normal B-cells as well as in mature B-cell malignancies, making it a promising target for DLBCL.3

The approval of polatuzumab vedotin is based on results from the Phase III POLARIX trial (NCT03274492), which compared the safety and efficacy of pola + R-CHP versus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in 879 patients with previously untreated LBCL.1 This trial demonstrated that patients receiving pola + R-CHP had a significantly improved progression-free survival (PFS) and modified event-free survival (EFS). At a follow-up of 28.2 months, the median PFS in the pola + R-CHP arm was 76.7% versus 70.2% in the R-CHOP arm.4 No significant difference was observed in overall survival (OS) at final analysis.1

At the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO), Jonathan Friedburg, MD, MMSc, University of Rochester, Rochester, NY, discussed the changing treatment landscape of DLBCL, highlighting the growing importance of pola + R-CHP. Dr Friedburg states, “It looks like we are curing more patients with this [pola + R-CHP] regimen, and saving patients the morbidity and potential mortality of relapse is a worthwhile endeavor.

The most common adverse events (AEs) associated with pola + R-CHP included peripheral neuropathy, fatigue, nausea, diarrhea, constipation, alopecia and mucositis.1 Patients should be monitored for these as well as other serious AEs.

Polatuzumab vedotin is the first ADC approved in the frontline setting for DLBCL and is expected to provide a valuable new treatment option for patients with previously untreated disease and those who may not respond well to standard therapy.


  1. U.S. Food and Drug Administration. FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not. (Last accessed 21/04/2023) 
  2. Sehn LH, Hertzberg M, Opat S, et al. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data. Blood Advances. 2022 Jan 25;6(2):533-543.
  3. Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Journal of Clinical Oncology. 2020 Jan 10;38(2):155-165.
  4. Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. 2022 Jan 27;386(4):351-363.

Written by Anya Dragojlovic-Kerkache
Edited by Thomas Southgate