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FDA Approved for NDMM Transp. Ineligible: Daratumumab + Lenalidomide & Dexamethasone




On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.


Approval was based on MAIA (NCT02252172), an open-label, randomized (1:1), active-controlled phase 3 study, comparing dartumumab (16 mg/kg) in combination with lenalidomide and low-dose dexamethasone (DRd) to lenalidomide and low-dose dexamethasone (Rd), in 737 patients with newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplant.

 

Learn more:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-multiple-myeloma-ineligible-autologous-stem-cell-transplant


06/27/2019: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761036Orig1s020ltr.pdf



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