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Daratumumab Triplet Nears EU Approval for Frontline Transplant-Ineligible Myeloma

Jason M. Broderick @jasoncology
Published: Friday, Oct 18, 2019

Jan van de Winkel, PhD

Jan van de Winkel, PhD
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed approval of daratumumab (Darzalex) for use 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 transplantation (ASCT).1

The FDA approved the DRd regimen in June 2019 for use in this setting.

References

  1. CHMP Issues Positive Opinion Recommending DARZALEX® (Daratumumab) in Combination with Lenalidomide and Dexamethasone in Frontline Multiple Myeloma. Genmab. Published October 18, 2019. Accessed October 18, 2019. https://bit.ly/33IcQIo.
  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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