FDA Accelerates Path for Bristol Myers Squibb's Opdivo-Based Combination Therapy in Hodgkin Lymphoma Treatment

Bristol Myers Squibb secured a significant regulatory milestone this week as the U.S. Food and Drug Administration fast-tracked its supplemental Biologics License Application for an innovative treatment combination. The agency has assigned an April 8, 2026 review target date, marking an expedited pathway under the Prescription Drug User Fee Act framework.

Expanded Treatment Option for Advanced Lymphoma Patients

The regulatory advancement centers on Opdivo (nivolumab) paired with a chemotherapy regimen comprising doxorubicin, vinblastine, and dacarbazine—commonly referenced as AVD. This combination therapy targets a critical patient population: both adult and pediatric patients aged 12 and older who have never received prior treatment for Stage III or IV classical Hodgkin Lymphoma (cHL). The priority review designation underscores the FDA’s recognition of potential clinical benefits in this treatment-resistant disease category.

Clinical Evidence Supporting Approval

The regulatory submission rests on robust Phase 3 clinical trial data from the SWOG S1826 study (protocol CA2098UT). This research specifically evaluated the safety and efficacy of Opdivo combined with AVD in previously untreated advanced-stage Hodgkin Lymphoma patients across both adult and pediatric populations aged 12 years and above. The study’s compelling results provided the foundation for the FDA’s decision to grant priority review status rather than standard evaluation timelines.

This accelerated review process reflects the agency’s commitment to advancing treatment options in oncology, particularly for patients facing historically challenging diagnoses. With the April 2026 PDUFA goal date now in place, Bristol Myers Squibb’s combination therapy moves closer to potential market availability for eligible patient populations.