In November 2022, the FDA approved Adcetris (brentuximab vedotin; from Seagen), a CD30-directed antibody–drug conjugate, in combination with a chemotherapy regimen for pediatric patients aged 2 years or older with high-risk classical Hodgkin lymphoma who have not received previous therapy. This is the first approval of Adcetris for pediatric patients. It was previously approved for this condition in adults.
The FDA approved Adcetris plus chemotherapy for young patients based on results of a randomized, open-label, actively controlled clinical trial that included 600 patients with classical Hodgkin lymphoma. The patients were divided into 2 groups to receive either Adcetris plus chemotherapy or chemotherapy alone.
The average time of event-free survival, defined as the time from randomization to the earliest of disease progression or disease relapse (coming back), second cancer, or death from any cause, was not reached in either group, meaning that most patients continued to benefit from their treatment and did not have disease progression or other serious events.
The most common serious side effects with Adcetris plus chemotherapy in pediatric patients were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection.
