Daratumumab and Hyaluronidase-fihj Combination Approved for Relapsed/Refractory MM

The FDA has approved daratumumab and hyaluronidase-fihj, in combination with pomalidomide and dexamethasone (Pd), for the treatment of patients with relapsed or refractory MM. This indication includes patients whose disease is refractory to lenalidomide.

This decision is based on results from the phase III APOLLO study, which enrolled 304 patients with relapsed or refractory MM who had experienced disease progression after treatment with lenalidomide and a proteasome inhibitor.

Daratumumab and hyaluronidase-fihj plus Pd reduced the risk of progression or death by 37% when compared with Pd alone. Median progression-free survival (PFS) for patients receiving daratumumab and hyaluronidase-fihj plus Pd was 12.4 months, compared with 6.9 months for patients in the Pd-only group. Rates of overall response, complete response or better, and very good partial response or better in the daratumumab and hyaluronidase-fihj plus Pd arm were 69%, 25%, and 51%, respectively, versus 46%, 4%, and 20%, respectively, in the Pd-only group. In addition, 9% of patients treated with daratumumab and hyaluronidase-fihj plus Pd showed minimal residual disease negativity, compared with 2% who received Pd alone.

Adverse events (AEs) occurring in ≥20% of patients included fatigue, pneumonia, upper respiratory tract infection, and diarrhea. Fatal AEs occurred in 7% of patients who were treated with daratumumab and hyaluronidase-fihj plus Pd, and 2% of patients permanently discontinued treatment because of an AE.

Source: Janssen press release, July 12, 2021.