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EU Approval Sought for Frontline Daratumumab/Rd in Transplant-Ineligible Myeloma

Gina Columbus @ginacolumbusonc
Published: Friday, Mar 22, 2019

Jose Antonio Buron Vidal

Jose Antonio Burun Vidal

A Type II variation application has been submitted to the European Medicines Agency for the combination of daratumumab (Darzalex) 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 combination is also being reviewed by the FDA under the Real-Time Oncology Review pilot program.

References

  1. Janssen Seeks Expanded Use of DARZALEX (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible. Janssen. Published March 22, 2019. Accessed March 22, 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.

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