Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) announced on Thursday that the US Food and Drug Administration (FDA) has accepted and granted priority review to its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in patients aged 12 and older.

The FDA set a Prescription Drug User Fee Act target action date of 8 April 2026.

The submission is supported by results from the Phase 3 SWOG S1826 study evaluating the Opdivo and AVD regimen in both adult and paediatric populations. Bristol Myers Squibb said that this combination has the potential to become a new first-line standard of care for advanced cHL.

Classical Hodgkin lymphoma accounts for most Hodgkin lymphoma cases and remains a high-risk condition for relapse and treatment-related toxicity despite therapeutic advances.

The company highlighted the need for options that provide durable outcomes early in the treatment course and said that it plans to work with the FDA throughout the review process.