European regulator validates B-MS Opdivo application for classical Hodgkin lymphoma

1 April 2016

US pharma major Bristol-Myers Squibb (NYSE: BMY) has had an application validated by the European Medicines Agency (EMA) to extend indications for Opdivo (nivolumab) to treat classical Hodgkin lymphoma (cHL) patients after prior therapies.

The type II variation application included data from the CheckMate-205 data study, which tested Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin.

Validation from the EMA confirms the submission is complete and the agency’s centralized review process for the application now begins.

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