Onco-Summaries: Daily Oncology Updates at a Glance

11/12/2025

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• BMS' sBLA for Opdivo + AVD received the FDA priority review for first-line cHL

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BMS' sBLA for Opdivo + AVD received the FDA priority review for first-line cHL (Ref) 

The US FDA granted priority review status to Bristol Myers Squibb's sBLA for nivolumab (Opdivo; anti-PD-1) + 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 PDUFA goal date of Apr 08, 2026

• The filing acceptance was based on the Phase 3 SWOG S1826/CA2098UT trial

• Monica Shaw, SVP, Oncology Commercialization, Bristol Myers Squibb: “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.

  
  

  • 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.”