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European Medicines Agency Validates Bristol-Myers Squibb’s Application for Opdivo(nivolumab) for the Treatment of Classical Hodgkin Lymphoma Patients

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Additional Relevant Details The European Medicines Agency (EMA) validated a type II variation application, which seeks to extend the current indications for Opdivoto include the treatment of 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. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
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Occurred on:
Mar 30, 2016
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Related Keywords Hematological Malignancy, Checkmate -205, Relapsed Or Refractory Chl, Opdivo, Brentuximab Vedotin, Autologous Stem Cell Transplant, Hodgkin Lymphoma