The U.S. Food and Drug Administration (FDA) has approved Janssen’s daratumumab and hyaluronidase-fihj combination therapy for adults with newly diagnosed amyloid light chain (AL) amyloidosis. 

AL amyloidosis is a rare blood disorder associated with the overproduction of amyloid, which leads to the deterioration of vital organs, most notably the heart, kidneys, and liver. Prior to this approval, there were no approved therapies for the treatment of AL amyloidosis, though a combination of bortezomib, cyclophosphamide, and dexamethasone (VCd) was commonly offered to AL amyloidosis patients.

The FDA approval of daratumumab and hyaluronidase-fihj in combination with VCd (D-VCd) was based on the positive results of the phase 3 ANDROMEDA study. The primary endpoint of this study – complete hematologic response rate – was met. Data showed hematologic response rates were higher in AL amyloidosis patients who were treated with D-VCd compared to VCd alone (53% vs. 18% respectively). Additionally, D-VCd was shown to have a safety profile consistent with those previously observed in each of the independent agents. The most common adverse reactions were upper respiratory tract infection, diarrhea, peripheral edema, constipation, fatigue, peripheral sensory neuropathy, nausea, insomnia, dyspnea, and cough. 

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