FDA Approves J&J’s Darzalex Faspro Combo for Multiple Myeloma

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.