Genmab Announces Submission of Biologics License Application to U.S. FDA for Subcutaneous Formulation of Daratumumab

World News: . []

“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 24 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 24 European Hematology Association Annual Congress.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

Company Announcement no. 33CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Globe Newswire: 16:43 GMT Friday 12th July 2019

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