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FDA Approval Sought for Frontline Daratumumab Regimen in Transplant-Eligible Myeloma

Gina Columbus @ginacolumbusonc
Published: Tuesday, Mar 26, 2019

Yusri Elsayed, MD, MHSc, PhD

Yusri Elsayed, MD, MHSc, PhD

A supplemental biologics license application (sBLA) has been submitted to the FDA for daratumumab (Darzalex) in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1


References

  1. Janssen Submits Application for DARZALEX (daratumumab) Combination Therapy to U.S. FDA for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma. Janssen. Published March 26, 2019. https://prn.to/2Ou6rue. Accessed March 26, 2019.
  2. Genmab Announces Positive Topline Results in Phase III CASSIOPEIA Study of Daratumumab in Front Line Multiple Myeloma. Genmab. Published October 21, 2018. https://bit.ly/2WpwMvY. Accessed March 26, 2019.
  3. 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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