Adcetris Approved as Initial Treatment for Stage III or IV Classical Hodgkin Lymphoma

May 2018, Vol 8, No 5 - FDA Approvals, News & Updates


On March 20, 2018, the FDA approved a new indication for brentuximab vedotin (Adcetris; Seattle Genetics) as a first-line treatment, in combination with chemotherapy, for adults with untreated stage III or stage IV classical Hodgkin lymphoma. The FDA approved this indication using its priority review process and designated brentuximab vedotin as a breakthrough therapy.

“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.

This new indication was based on results from the ECHELON-1 clinical trial of 1334 treatment-naïve patients with stage III or IV classical Hodgkin lymphoma that compared brentuximab vedotin plus chemotherapy versus chemotherapy alone. After an average of 6 28-day cycles, patients who received brentuximab vedotin plus chemotherapy had a 23% reduced mortality risk, started a new treatment, or had disease progression versus those who received chemotherapy alone.

The most common (≥20%) adverse reactions associated with brentuximab vedotin are neutropenia, anemia, peripheral sensory neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and pyrexia.