Janssen Biotech applied to EMA for extension of the Darzalex marketing authorization for subcutaneous formulation in multiple myeloma indications.

Genmab A/S announced that its licensing partner, Janssen Biotech, Inc., has submitted an application for the extension of the Darzalex marketing authorization to the European Medicines Agency (EMA). This application seeks approval for the use of the subcutaneous (SubQ) formulation of daratumumab in multiple myeloma indications where the intravenous formulation of daratumumab is currently approved. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

The submission is based on data from two ongoing studies: the Phase III non-inferiority COLUMBA study, which is comparing the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma and preliminary non-public data from the Phase II PLEIADES study, which is evaluating daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA data were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology Annual Meeting and the 24th European Hematology Association Annual Congress.