Bristol Myers Squibb shared a post on X:
“Announcing the U.S. FDA has granted priority review of the application for our immunotherapy-based combination for adult and pediatric patients with previously untreated Stage III or IV Classical Hodgkin Lymphoma.”
U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb’s Application for Opdivo (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma
The U.S. FDA assigned a target action date of April 8, 2026
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.
Monica Shaw, Senior Vice President, Oncology Commercialization, Bristol Myers Squibb, said:
“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.”
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.
Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 SWOG S1826 (CA2098UT) study.
About SWOG S1826 (CA2098UT)
SWOG S1826, also known as CA2098UT, is a randomized, multicenter, Phase 3 study evaluating 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 study is designed to assess progression-free survival as the primary endpoint, with key secondary endpoints that include overall survival and other measures of efficacy and safety. The SWOG S1826 study is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), under a Cooperative Research and Development Agreement with Bristol Myers Squibb and conducted in the NCI National Clinical Trials Network (NCTN) led by the SWOG Cancer Research Network.
It is the largest cHL study conducted in the NCTN. Bristol Myers Squibb co-sponsored the study and supplied Opdivo to the NCI through a Cooperative Research and Development Agreement.
About Classical Hodgkin Lymphoma
Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. HL is the most common cancer diagnosed in adolescents (ages 15-19). It is most often diagnosed in early adulthood (ages 20-39) and late adulthood (older than 55 years of age).
Classical Hodgkin lymphoma is the most common type of HL, accounting for 95% of cases. Despite progress in frontline therapy, advanced-stage HL still carries a substantial risk of relapse and treatment-related toxicity, highlighting the need for innovative approaches that deliver durable remission with less burden for patients.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.
The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan, and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
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