FDA approval of new indication for Adcetris + chemotherapy for children with previously untreated high risk Hodgkin lymphoma

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). Patients had a 59% reduction in the risk of disease progression or relapse, second cancer or death (Hazard ratio 0.41 [95% Confidence Interval: 0.25, 0.67]; p=0.0002).

Hodgkin lymphoma is blood cancer that starts when lymphocytes, a type of white blood cell, grow out of control. It represents about 6% of all childhood cancers and is the most common cancer diagnosed in adolescents ages 15 to 19 years. About one-third of all Hodgkin lymphoma patients are classified as high risk, typically stage IIB, IIIB, and IVA or IVB. People with cHL have abnormal white blood cells that usually have a special protein on their surfaces called CD30, a key marker of cHL.