Genmab receives additional FDA Approval for Daratumumab
Genmab announced today that the U.S. Food and Drug Administration (FDA) has approved the use of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., under the Real-Time Oncology Review (RTOR) pilot program. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
“The combination of lenalidomide and dexamethasone is broadly used by newly diagnosed patients with multiple myeloma ineligible for ASCT in the United States. We are extremely pleased that physicians can now offer their patients the option to add DARZALEX to this regimen in the U.S.,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The approval was based on data from the Phase III MAIA (MMY3008) study of daratumumab in combination with lenalidomide and dexamethasone as treatment for patients with newly diagnosed multiple myeloma, who are not candidates for high dose chemotherapy and ASCT. Data from this study was presented as a Late-Breaking Abstract at the 2018 American Society of Hematology (ASH) Annual Meeting in December 2018.
Source: Genmab
