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Subcutaneous daratumumab and hyaluronidase-fihj in newly diagnosed or relapsed/refractory multiple myeloma.

Authors:
Larysa Sanchez Joshua Richter Hearn Jay Cho Sundar Jagannath Deepu Madduri Samir Parekh Shambavi Richard Lowena Tam Daniel Verina Ajai Chari

Ther Adv Hematol 2021 22;12:2040620720987075. Epub 2021 Jan 22.

Multiple Myeloma Program, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, Box 1185, New York, NY 10029, USA.

Daratumumab, a human immunoglobulin G1 kappa monoclonal antibody that targets CD38, is currently approved as monotherapy and in varying combinations with approved anti-myeloma regimens in both newly diagnosed multiple myeloma and relapsed refractory multiple myeloma. Originally developed for intravenous administration, the subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) was recently approved by the US Federal Drug Administration and European Commission in 2020. In clinical trials, compared with the intravenous formulation, subcutaneous daratumumab (Dara-SC) has significantly shorter administration time (median first dose 7 h 3-5 min, respectively), lower rates of infusion-related reactions (median first dose 50% less than 10%, respectively), and lower volume of infusion (median 500-1000 ml 15 ml, respectively). Otherwise, the pharmacokinetics, safety profile, and efficacy are comparable. This review summarizes the pivotal trials that led to the approval of Dara-SC, highlights important clinical considerations for the use of Dara-SC, and provides practical guidelines for the administration of Dara-SC in the clinic.

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http://dx.doi.org/10.1177/2040620720987075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841854PMC
January 2021

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