Genmab: Janssen files for myeloma drug expansion in Europe

(CercleFinance.com) - Denmark's Genmab said that partner Janssen has submitted an application to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorisation for Darzalex.


This application seeks to expand the drug's label to include use, in combination with bortezomib, thalidomide and dexamethasone (VTD), as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant.

Yesterday Janssen submitted an application to the US FDA for the same indication.

For the record, Genmab has granted Janssen an exclusive worldwide license to develop, manufacture and commercialize Darzalex.

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