Bristol Myers Squibb announced that the FDA has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 8, 2026.
“The FDA’s acceptance of our supplemental Biologics License Application for priority review marks a pivotal milestone as we aim to bring a new and much-needed first-line option to adolescents and adults newly diagnosed with advanced-stage classical Hodgkin lymphoma,” said Monica Shaw, Senior Vice President, Oncology Commercialization, Bristol Myers Squibb. “Opdivo in combination with AVD represents a potential new standard of care in the frontline treatment of advanced cHL for adolescents and adults. Hodgkin lymphoma remains a challenging disease, with an ongoing need for therapies that may deliver meaningful and durable outcomes early in a patient’s treatment journey. We look forward to collaborating with the FDA throughout the review process to bring this important option to patients as quickly as possible.”
The FDA filing acceptance is based on the Phase 3 SWOG S1826 (CA2098UT) study, evaluating Opdivo in combination with AVD for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV cHL.
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