Darzalex (daratumumab) plus bortezomib and dexamethasone filed with EU for multiple myeloma- Genmab/ Janssen
Genmab announced that Janssen Pharmaceutica has submitted a variation to the Marketing Authorization to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorization for Darzalex (daratumumab) plus bortezomib and dexamethasone to include treatment of adult patients with multiple myeloma who have received at least one prior therapy. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
The submission includes data from two Phase III studies: the CASTOR study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma, and the POLLUX study of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The submission also included data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma.
Janssen submitted a supplemental Biologics License Application for daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of patients with multiple myeloma who received at least one prior therapy to the U.S. Food and Drug Administration in August 2016.
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