News Related to Newly Diagnosed Multiple Myeloma

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FDA Approves Subcutaneous Isatuximab; Phase 3 Trial Shows MRD Benefit in Myeloma

Jul 10, 2026

FDA approved subcutaneous isatuximab-irfc for multiple myeloma. Phase 3 EMN24 trial showed 77% MRD negativity with Isa-KRd quadruplet therapy. Phase 2 study showed 77% hematologic response rate in relapsed/refractory AL amyloidosis.

FDA Approves Two Johnson & Johnson Multiple Myeloma Regimens in Early 2026

Mar 06, 2026

The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.