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Adcetris Approved as Initial Treatment for Advanced Classical Hodgkin Lymphoma

On March 20, 2018, the FDA approved Adcetris (brentuximab vedotin; from Seattle Genetics) as the first treatment, in combination with chemotherapy, for adults with untreated stage III or IV classical Hodgkin lymphoma.

“Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

In the clinical trial that led to this approval, patients with advanced, stage III or IV, classical Hodgkin lymphoma who had not received treatment showed improvement with Adcetris plus chemotherapy compared with chemotherapy alone. Overall, patients who received Adcetris plus chemotherapy had a 23% lower risk of dying or having disease progression compared with those who received chemotherapy alone.

The most common side effects associated with Adcetris are neutropenia, anemia, neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and fever.