FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

FDA

12 July 2021 - On 9 July 2021, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Efficacy was evaluated in APOLLO, an open-label, active-controlled trial with 304 patients randomised (1:1) to Darzalex Faspro with pomalidomide and dexamethasone versus pomalidomide alone.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US