www.fdanews.com/articles/203527-fda-approves-jjs-darzalex-faspro-combo-for-multiple-myeloma
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FDA Approves J&J’s Darzalex Faspro Combo for Multiple Myeloma
July 13, 2021
Johnson & Johnson’s (J&J) Darzalex Faspro (daratumumab and hyaluronidase-fihj) has received FDA approval when combined with pomalidomide and dexamethasone as a second-line therapy for treating adults with multiple myeloma.
The new indication — Darzalex Faspro’s sixth — was supported by phase 3 results which showed the combination therapy reduced the risk of disease progression or death by 37 percent vs. pomalidomide and dexamethasone alone.
Darzalex Faspro is the only subcutaneous anti-CD38 monoclonal antibody cleared for use with the anti-cancer regimen pomalidomide and dexamethasone.