BMS files sBLA at FDA for Opdivo (nivolumab) to treat classical Hodgkin lymphoma.
BMS announced that the FDA accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate -205 data, which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. The FDA granted the application a priority review and previously granted Opdivo Breakthrough Therapy Designation for cHL on May 14, 2014. According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
CheckMate 205 is a Phase II study evaluating the safety and efficacy of Opdivo in patients with relapsed or refractory cHL. Data from this trial are expected to be presented at a medical meeting later this year.
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