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Daratumumab, lenalidomide and dexamethasone granted positive opinion by EMA CHMP

Oct 23, 2019

During the October meeting of the European Medicines Agency(EMA) Committee for Medicinal Products for Human Use(CHMP), a positive opinion was granted to daratumumab (D) plus lenalidomide (R) and dexamethasone (d, D-Rd) for the treatment of adult patients with newly diagnosed (ND) multiple myeloma (MM, NDMM) who were ineligible for transplant. The CHMP recommended that the marketing authorization for daratumumab should be amended. 1,2Dara-Rd was previously approvedby the United States (U.S.) Food & Drug Administration(FDA) in the same setting. 3

Current EMA approvals for D

In Europe, D is currently approved; 1

  • In combination with bortezomib (V), melphalan (M) and prednisone (P, VMP) for adult patients with NDMM who are ineligible for transplant
  • In combination with Rd, or Vd, for adult patients with MM who have received ≥ one prior therapy
  • As monotherapy for adult patients with relapsed/refractory MM who have previously received treatment with a proteasome inhibitor and an immunomodulatory agent, and who have experienced disease progression from last therapy


The EMA CHMP positive opinion is based on the results from MAIA, an international phase III trial comparing D-Rd to Rd in patients with NDMM who are ineligible for transplant. The interim resultswere presented at the 60 thAmerican Society of Hematology Exposition and Meeting, 2018, and were published in The New England Journal of Medicine in May 2019.

As of 24 thSeptember 2018, D-Rd provided a 44% reduction in the risk of progression or death compared to Rd alone, with measurable residual disease (MRD) rates that were three-fold higher.

  • D-Rd (n= 368) vsRd (n= 369)
  • Median follow-up: 28 months
  • PFS (D-Rd vsRd): Not reached (NR) vs31.9 months (95% CI, 49.5–61.3)
  • Hazard ratio for disease progression or death in D-Rd arm vsRd arm: 0.56
    • 95% CI: 0.43–0.73, p< 0.001
  • MRD negativity (D-Rd vsRd): 24% vs7%, p< 0.001
  • Main treatment emergent adverse events grade III–IV (D-Rd vsRd):
    • Neutropenia: 50% vs35%
    • Anemia: 12% vs20%
    • Lymphopenia: 15% vs11%
    • Pneumonia: 14% vs8%
  1. Summary of opinion: Darzalex.[Accessed 2019 Oct 22]
  2. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019.[Accessed Oct 22]
  3. FDA approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant.[Accessed 2019 Oct 23]
  4. Facon T. et al., Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. New Eng J Med. 2019 May 30. DOI: 10.1056/NEJMoa1817249