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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.1,2 Dara-Rd was previously approved by the United States (U.S.) Food & Drug Administration (FDA) in the same setting.3
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 results were presented at the 60th American Society of Hematology Exposition and Meeting, 2018, and were published in The New England Journal of Medicine in May 2019.
As of 24th September 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.
References
Your opinion matters
Are you currently re-using anti-CD38 therapy in patients with multiple myeloma who have been previously exposed but were not refractory to it?