publication date: Jun. 7, 2019
Drugs & Targets FDA grants Priority Review for daratumumab combination in multiple myeloma
Genmab A/S announced FDA granted a Priority Review for the supplemental Biologics License Application for the use of daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant.
The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech Inc., in March 2019. FDA assigned a Prescription Drug User Fee Act target date of Sept. 26 to take a decision on daratumumab in this indication. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture, and commercialize daratumumab.
The sBLA submission is based on data from the phase III CASSIOPEIA study of daratumumab in combination with VTd as treatment for patients newly diagnosed with multiple myeloma who are candidates for ASCT.
The study is sponsored by the French Intergroupe Francophone du Myelome in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and Janssen.
Genmab announced topline results from the trial in October 2018 and ASCO accepted an abstract containing more complete data, submitted by Janssen, for oral presentation at the 2019 annual meeting.
Daratumumab is a human IgG1k monoclonal antibody that binds with high affinity to the CD38 molecule, … Continue reading FDA grants Priority Review for daratumumab combination in multiple myeloma
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