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Rolling Submission Completed for Daratumumab/Rd in Frontline Transplant-Ineligible Myeloma

Gina Columbus and Jason M. Broderick
Published: Wednesday, Mar 13, 2019

Yusri Elsayed, MD, MHSc, PhD

Yusri Elsayed, MD, MHSc, PhD

A supplemental biologics license application (sBLA) has been submitted to the FDA for the approval of daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).1

The FDA previously approved daratumumab was previously approved in multiple myeloma for use in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment patients who are ineligible for ASCT, but the VMP regimen is mainly utilized in Europe.


  1. Janssen Submits Application to U.S. FDA Seeking Approval of DARZALEX® (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible. Janssen. Published March 13, 2019. Accessed March 13, 2019.
  2. 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: 2018 ASH Annual Meeting; December 4-8, 2018; San Diego, CA. Abstract LBA-2.

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