Bristol Myers Squibb Gets FDA Priority Review for Opdivo Plus AVD Combination sBLA In Untreated Stage III/IV cHL; PDUFA April 8, 2026

Benzinga · 2d ago

Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (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 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.