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FDA Grants Frontline Daratumumab Regimen Priority Review in Transplant-Eligible Myeloma

Jason M. Broderick @jasoncology
Published: Friday, May 31, 2019

Jan van de Winkel, PhD
Jan van de Winkel, PhD
The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) 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).

In March, Janssen submitted an sBLA to the FDA for the approval of daratumumab in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT.
Moreau P, Attal M, Hulin C, et al. Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results. J Clin Oncol.2019;37(suppl; abstr 8003).

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