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Frontline Daratumumab Triplet Approved in EU for Transplant-Ineligible Myeloma

Gina Columbus
Published: Tuesday, Nov 19, 2019

Jan van de Winkel, PhD

Jan van de Winkel, PhD
The European Commission has approved the triplet regimen of daratumumab (Darzalex) with lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).1

The most frequently occurring nonhematologic TEAEs in the DRd arm included pneumonia (14% vs 8% with Rd); fatigue (8% vs 4%); diarrhea (7% vs 4%); deep vein thrombosis, pulmonary embolism, or both (6% in each arm); asthenia (4% in each arm); back pain (3% in each arm); constipation (2% vs <1%); peripheral edema (2% vs <1%); and nausea (1% vs ≤1%).

References

  1. Genmab announces European Marketing Authorization for DARZALEX® (Daratumumab) in combination with lenalidomide and dexamethasone in frontline multiple myeloma. Genmab. Published November 19, 2019. https://bit.ly/2XtWAZH. Accessed November 19, 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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