EMA Validates BMS application for Opdivo for the treatment of classical Hodgkin lymphoma patients
Opdivo has potential to become first PD-1 inhibitor approved in a hematological malignancy in European Union.
Bristol-Myers Squibb (BMS) has announced that the European Medicines Agency (EMA) has validated a type II variation application, which seeks to extend the current indications for Opdivo to 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.
“We are eager to continue to extend the use of Opdivo as a treatment option and potentially provide hematology with its first PD-1 inhibitor, a type of treatment that is designed to work with the PD-1 pathway and leverage the immune system to help fight classical Hodgkin lymphoma,” said Jean Viallet, Oncology Global Clinical Research Lead, Bristol-Myers Squibb. “We are hopeful to build on expanding our hematology franchise and bring the science of Immuno-Oncology to these adult relapsed and refractory classical Hodgkin lymphoma patients in Europe who often have limited remaining treatment options.”
CheckMate -205 is a Phase II study evaluating the safety and efficacy of Opdivo in patients with relapsed or refractory cHL. The results of this trial are expected to be presented at a medical meeting later this year.
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