Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (U.S. FDA) 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.
‘Should this submission lead to an approval, it would provide patients with a treatment option that combines efficacy comparable with intravenous DARZALEX with a subcutaneous delivery that reduces treatment time from hours to just minutes. Not only would this be more convenient for patients but, as we saw with the COLUMBA data recently presented at the 2019 ASCO Annual Meeting and 24th EHA Annual Congress, infusion-related reactions are both mild and significantly reduced with this formulation of daratumumab,’ said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. ‘Subcutaneous daratumumab may also provide an attractive option for health care providers, especially in the community setting, where reducing the administration time can be very important.’
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 24thEuropean Hematology Association Annual Congress.
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