FDA Grants Priority Review to supplemental BLA for Opdivo® + Chemo Combo for Classical Hodgkin Lymphoma
“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,” said Monica Shaw, Senior Vice President, Oncology Commercialization, Bristol Myers Squibb. “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.”
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