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FDA Approval Sought for Daratumumab/Rd for Frontline Transplant-Ineligible Myeloma

Jason M. Broderick @jasoncology
Published: Tuesday, Jan 22, 2019

Jan van de Winkel, PhD

Jan van de Winkel, PhD
A supplemental Biologics License Application (sBLA) has been initiated with the FDA for daratumumab (Darzalex) for use in combination with lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant (ASCT).

Facon T, Kumar SK, Plesner T, et al. Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA). Presented at: ASH Annual Meeting and Exposition; December 4-8, 2018; San Diego, California. Abstract LBA-2.

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