BRIEF—New FDA indication for Adcetris

The US Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) for the treatment of pediatric patients two years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.

Adcetris is US biotech Seagen’s bestselling drug, pulling in third-quarter 2022 sales of $219 million, a year-on-year rise of 18%.

The approval is based on data from a Phase III study ( AHOD1331) conducted by the Children's Oncology Group (COG) and funded by the National Cancer Institute that showed patients receiving Adcetris in combination with standard of care dose-intensive chemotherapy AVE-PC (Adriamycin [doxorubicin], vincristine, etoposide, prednisone and cyclophosphamide) had superior event-free survival (EFS) compared to patients who received standard of care chemotherapy ABVE-PC (Adriamycin [doxorubicin], bleomycin, vincristine, etoposide, prednisone and cyclophosphamide).

“Adcetris is a ground-breaking medicine approved for adults with certain types of lymphomas. Today’s FDA approval extends its availability to younger patients with high-risk classical HL,” said Dr Marjorie Green, senior vice president and head of late-stage development, Seagen.