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FDA Approves Frontline Daratumumab/Rd in Transplant-Ineligible Myeloma

Gina Columbus @ginacolumbusonc
Published: Thursday, Jun 27, 2019

The FDA has approved the combination of daratumumab (Darzalex) with lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).1

"Today's approval of DARZALEX underscores the significant clinical benefit of this CD38 monoclonal antibody and our efforts to advance treatment paradigms to change the course of the disease," Craig Tendler, MD, vice president, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC, the developer of daratumumab, stated in the press release. "Importantly, this milestone also highlights the efficiency of the FDA's Real-Time Oncology Review process, ensuring that proven treatment regimens, such as DARZALEX plus lenalidomide and dexamethasone, are made available to patients as soon as possible."

References

  1. Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible . Janssen. Published June 27, 2019. https://prn.to/2ZSPDkN. Accessed June 27, 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. 
  3. Facon T, Kumar S, Plesner T, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Eng J Med. 2019;380:2104-2115. doi: 10.1056/NEJMoa1817249. 

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