The FDA’s decision was based on positive results from the phase 3 AHOD1331 study in which patients receiving the combination treatment achieved superior event-free survival compared to patients who received standard of care chemotherapy alone.
AHOD1331 is, as the company reports, the largest multicentre, randomised, open-label phase 3 immunotherapy study ever conducted with newly diagnosed high risk Hodgkin lymphoma (HL) paediatric patients.
The study enrolled 587 patients aged from two to 21 years across 151 institutions who had previously untreated Hodgkin lymphoma (HL) classified as high risk.
