Today, the FDA approved daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients who who were ineligible for ASCT or refused ASCT as initial therapy. The decision further solidifies this anti-CD38 antibody-based regimen as a cornerstone of care in this setting.

In comments shared with SurvivorNet Connect, Dr. Robert Z. Orlowski, a globally renown expert in multiple myeloma care and the Deputy Chair of Lymphoma and Myeloma department at MD Anderson Cancer Center in Houston, emphasized the broader clinical impact of the approval. “This approval expands treatment options for patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, and further establishes the role of CD38 targeting using either daratumumab or isatuximab in addition to the bortezomib/lenalidomide/

Dr. Sagar Lonial, another leading authority in multiple myeloma research and a medical oncologist at Emory University Winship Cancer Institute in Atlanta, highlighted the practical implications for patients unable to pursue a transplant: “This approval opens the door for Quad-based therapy using daratumumab for patients who are not moving forward with transplant either planned or are not of the age or functional status to proceed down that road. This is an important development as daratumumab is one of the most commonly given CD38 antibodies used currently, and this allows for more intensive induction for all patients and which for the right patients we know can improve outcomes.”
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