The United States Food and Drug Administration accepted and granted priority review to a supplemental Biologics License Application for nivolumab (Opdivo) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult patients and pediatric patients who are 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma. The Prescription Drug User Fee Act target action date is April 8, 2026.
The application is based on the phase 3 SWOG S1826 study, sponsored by the National Cancer Institute and led by the SWOG Cancer Research Network. Bristol Myers Squibb co-sponsored the study and supplied nivolumab to the NCI through a Cooperative Research and Development Agreement, according to a press release from BMS.
“Opdivo in combination with AVD represents a potential new standard of care in the frontline treatment of advanced cHL for adolescents and adults,” Monica Shaw, senior vice president of oncology commercialization at BMS, said in the release.
