New chemoimmunotherapy regimen for aggressive form of lymphoma gets FDA approval

A cancer therapy based on the work of Ben Seon, PhD, at Roswell Park Comprehensive Cancer Center has been approved by the U.S. Food and Drug Administration (FDA) for patients with an aggressive form of non-Hodgkin lymphoma. On June 10, the FDA granted accelerated approval to polatuzumab vedotin as part of a new chemotherapy/immunotherapy treatment combination for patients with relapsed or refractory diffuse large B-cell lymphoma -; a new chemoimmunotherapy regimen for this aggressive form of lymphoma.

Polatuzumab vedotin incorporates a form of immunotherapy known as a monoclonal antibody -; a manufactured protein that can bind to and kill tumor cells. Roswell Park has played a role in many other FDA-approved innovations in cancer treatment and diagnostics, including the work of Dr. T. Ming Chu in developing the PSA test for prostate cancer, Dr. Thomas Dougherty's work establishing photodynamic therapy (PDT) as a treatment option for some cancers and work by Dr. Ravindra Pandey and others to develop photosynthesizers used in PDT. The approval of polatuzumab vedotin marks the first time an immunotherapy from Roswell Park has been part of an FDA-approved treatment.

The FDA has discretion to grant accelerated approval to drugs that fill an unmet medical need in addressing a serious medical condition. Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in the United States and worldwide. More than 18,000 people in the U.S. are diagnosed with DLBCL each year.

Manufactured by Genentech Inc., polatuzumab vedotin is an antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B cells -; the immune cells that B-cell lymphoma affects. Beginning in the late 1980s, it was Dr. Seon, a member and Professor in the Department of Immunology at Roswell Park, who found a way to isolate CD79b and similar antigens, creating the specific antibody that would later become known as polatuzumab vedotin.

What Ben has done is really remarkable. Through his systematic, diligent approach, he came up with ideas decades ago in his lab that larger teams have only begun to hit upon in the last few years."

Kelvin Lee, MD, the Jacobs Family Chair in Immunology and Senior Vice President for Basic Science at Roswell Park

"Dr. Seon has played a fundamental role in the development of antibody-based therapy for lymphoma," notes Roswell Park Chief of Lymphoma Francisco Hernandez-Ilizaliturri, MD. "The results of the most recent clinical trials show that this is an effective combination for many patients, and we hope that this important new treatment option will help a number of patients in the future."

"I didn't take the conventional approach. I decided to develop a new system for isolating antigens," says Dr. Seon, a longtime Amherst, N.Y., resident. He is especially proud that a therapy he developed has helped many patients at Roswell Park, one of the participating sites in the clinical trials incorporating polatuzumab vedotin.

"My father died from stomach cancer when I was a high school student, and my brother died of cancer many years ago in his 50s," says Dr. Seon, whose work has been supported in part by donations to Roswell Park and by the National Institutes of Health. "So it's always been in my mind that hopefully someday I could find a new cancer drug, a better cancer drug."

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