Rye Brook, N.Y., April 20, 2023 – The U.S. Food and Drug Administration on Wednesday approved polatuzumab vedotin (Polivy®), an antibody-drug conjugate, in combination with chemotherapy for patients with previously untreated moderate to high risk diffuse large B-cell lymphoma (DLBCL), the most common form of lymphoma.
This combination was previously approved in 2019 by the FDA for use only after patients received two earlier types of treatment.
“The FDA’s decision gives newly diagnosed patients with this aggressive form of lymphoma their first new treatment option in nearly two decades,” says Lee Greenberger, Ph.D., Chief Scientific Officer of The Leukemia & Lymphoma Society. “One of our major goals at LLS is to support science that moves us toward less toxic, and more effective treatment options, and this drug combination is a step in that direction.”
The standard chemotherapy combination used for DLBCL, called R-CHOP, is highly effective for only about 60% of patients and it also has many side effects. Adding polatuzumab allows the removal of vincristine chemotherapy (the “O” in CHOP) from the combination.
Vincristine can suppress normal blood cell production and cause nerve toxicity, as well as adverse effects in many other systems in the body. Polatuzumab provides more targeted treatment, seeking out a specific surface protein called CD79b on rapidly dividing B cells, including cancerous B cells.
LLS supported the very first drugs of this type (called antibody-drug conjugates, or “ADCs”) approved over 20 years ago and continues to develop newer ADCs through research funding grants and philanthropic investments through the LLS Therapy Acceleration Program.
In the clinical trial that supported the FDA’s approval, patients were treated with either the polatuzumab/R-CHP combination or standard R-CHOP. A higher percentage of patients treated with polatuzumab/R-CHP had progression-free survival (defined as the time from start of treat to disease progression or death) compared to the R-CHOP group. However, the overall survival at 2 years did not differ significantly between the groups and the safety profile was similar.
“While this new drug is a valuable addition for some patients, we need to keep pressing forward to find even better options for DLBCL and every type of blood cancer,” says Dr. Greenberger. “But advances like polatuzumab are important, not just for today’s patients, but because science builds on itself, helping us to learn more about effective use of target drugs and harnessing the immune system to help tomorrow’s patients do even better.”