A Win Against Hodgkin Lymphoma

Of all the new pediatric cancer drugs that go through clinical trials, only about 5% ultimately get Food and Drug Administration approval. So when nivolumab, a new immunotherapy drug for Hodgkin lymphoma, got approval for patients 12 years old and up, it represented a rare win—and a major advance—in the fight against childhood cancer. 

The FDA approval was based on data from a clinical trial published in the New England Journal of Medicine in October 2024 and a subset analysis of the main trial published in the Journal of Clinical Oncology. The latter was focused specifically on the adolescent patients in the study and included longer follow-up data that confirmed the positive results with nivolumab. 

The trial found that teens and adults with advanced-stage Hodgkin lymphoma survive longer without their disease coming back when they receive nivolumab—as opposed to the immunotherapy brentuximab vedotin—alongside chemotherapy. The nivolumab combination also exhibited fewer side effects.

Kara Kelly, division chief of hematology/oncology in the Department of Pediatrics at the University at Buffalo and chair of the Golisano Children’s Cancer and Blood Disorders Program at Roswell Park Comprehensive Cancer Center, was senior pediatric oncology investigator, overseeing the inclusion of the adolescent patients in the trial. She and the other authors encouraged the FDA to approve nivolumab for stages 3 and 4 classic Hodgkin lymphoma and to lower to 12 the minimum age for receiving the new drug.

Subsequently, the National Comprehensive Cancer Center guidelines—the international gold standard for treatment recommendations—were updated to reflect the newly discovered best practice. The guidance was raised to a category 1 recommendation after FDA approval was gained. 

“We are excited about the FDA’s decision,” says Kelly, who also served as the site PI for all patients who enrolled in the trial locally through Roswell Park’s participation. “It’s the first time that the FDA approved a new drug for Hodgkin lymphoma in pediatric patients at the same time that they approved it for adults.”

Typically, she notes, it takes an average of six years after a cancer drug is approved in adults for it to be approved in children.

According to Benny Joyner, A. Conger Goodyear Professor and Chair of the Department of Pediatrics in the Jacobs School, “This is just the most recent demonstration of how the research that Dr. Kelly and her colleagues conduct translates into very real improvements in the lives of children with cancer.”