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# Opdivo–AVD Priority Review for Hodgkin Lymphoma
- URL: https://www.fdaweb.com/opdivo-avd-priority-review-for-hodgkin-lymphoma/
- Published: 2025-12-11T12:00:00.000Z
- Updated: 2026-09-14T15:29:00.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160374

FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD chemotherapy for adults and adolescents with previously untreated Stage III or IV classical Hodgkin lymphoma. The agency set a user fee review action date of 4/8/2026.

“This 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 classical Hodgkin lymphoma,” the company says in a release. It says the Opdivo–AVD combination “represents a potential new standard of care” and noted the persistent need for regimens that deliver durable outcomes early in the treatment course.

The submission is based on data from the Phase 3 SWOG S1826 (CA2098UT) trial, a randomized, multicenter study comparing Opdivo plus AVD against standard therapy in adults and adolescents aged 12 and up with newly diagnosed Stage III or IV disease. The primary endpoint is progression-free survival, with key secondary endpoints including overall survival, safety, and additional efficacy measures.

Opdivo, a PD-1 checkpoint inhibitor first approved in 2014, is currently authorized in more than 65 countries and across a wide range of tumor types, including melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma.