Dr. Nowakowski Gives an Inside Look at the FDA ODAC 'Yes' Vote to Polivy

By Chadi Nabhan, MD, MBA, FACP, Greg Nowakowski, MD - Last Updated: December 19, 2023

In this episode of The HemOnc Pulse, Grzegorz Nowakowski, MD, a Professor of Oncology and Medicine in the Division of Hematology at the Mayo Clinic, recounts his experience serving on the FDA Oncologic Drugs Advisory Committee (ODAC) that reviewed and evaluated data from the POLARIX study and polatuzumab vedotin-piiq (Polivy) for patients with previously untreated large B-cell lymphoma (LBCL).

Although Dr. Nowakowski was well-versed in the POLARIX study, he explained he still learned new information during the ODAC meeting.

“For example, reading the paper, I was under the impression that the central pathology review or some central review was performed,” he explained. “That’s what is typically done in most of the modern studies, but when I questioned the sponsor, it actually turned out that there was no central pathology reviewing the study, so it was only by local diagnosis.”

Dr. Nowakowski explained that these local centers do not see lymphoma cases often.

“Now, we know that in diffuse LBCL specifically there is a high discordance rate between the pathologist in terms of the review, particularly the local centers, which don’t necessarily see a high volume of lymphoma,” he said. “There could be some overlap with marginal zone lymphoma or with high-grade lymphoma.”

He also said that the FDA’s independent analysis revealed insightful data, especially in the subset analysis of patients with diffuse LBCL not otherwise specified. 

Editorial Board