FDA Approves Subcutaneous Isatuximab-irfc - Takeaways - MDSpire
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FDA Approves Subcutaneous Isatuximab-irfc

The approval expands subcutaneous use across newly diagnosed and previously treated multiple myeloma.

  • By

  • Kathryn Wighton

  • July 10, 2026

  • 2 min

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  • 1

    The FDA approved subcutaneous isatuximab-irfc for three indications in adult patients with multiple myeloma.

  • 2

    Isatuximab-irfc is approved with pomalidomide and dexamethasone for patients with prior therapy including lenalidomide.

  • 3

    The drug is also approved with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma.

  • 4

    For newly diagnosed multiple myeloma patients not eligible for stem cell transplantation, it is approved with bortezomib, lenalidomide, and dexamethasone.

  • 5

    The recommended dose is 1,400 mg subcutaneously, with warnings for hypersensitivity, neutropenia, and other risks.

Original Source(s)

FDA Approves Subcutaneous Isatuximab-irfc

  • by Kathryn Wighton

  • July 10, 2026

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