US pharma giant Bristol Myers Squibb has announced that the FDA has accepted and given priority review to its application for Opdivo (nivolumab) combined with AVD chemotherapy for adults and teens with untreated Stage III or IV classical Hodgkin lymphoma. 

 

The FDA aims to make a decision by 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’s review is supported by data from the Phase 3 SWOG S1826 study, which evaluated Opdivo plus AVD in adults and adolescents with previously untreated Stage III or IV cHL, the company has said.