The Food and Drug Administration approved daratumumab and hyaluronidase-fihj 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 (NCT03180736), an open-label, active-controlled trial with 304 patients randomised (1:1) to daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone (Pd) vs Pd alone.
Patients received daratumumab and hyaluronidase-fihj 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously once weekly from weeks 1 to 8, once every 2 weeks from weeks 9 to 24 and once every 4 weeks starting with week 25 until disease progression or unacceptable toxicity with pomalidomide 4 mg once daily orally on days 1-21 of each 28-day cycle; and dexamethasone 40 mg per week (or a reduced dose of 20 mg per week for patients >75 years).
The main efficacy outcome measure was progression-free survival (PFS).
The median PFS was 12.4 months in the daratumumab and hyaluronidase-fihj treatment group and 6.9 months in the Pd treatment group (HR 0.63; 95% CI: 0.47, 0.85; p=0.0018), representing a 37% reduction in the risk of disease progression or death for patients treated with daratumumab and hyaluronidase-fihj versus Pd.
The most common adverse reactions (≥20%) in patients with multiple myeloma who received daratumumab and hyaluronidase-fihj are fatigue, pneumonia, upper respiratory tract infection, and diarrhoea.
The recommended dosage of daratumumab and hyaluronidase-fihj is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to the recommended schedule.
View full prescribing information for daratumumab and hyaluronidase-fihj here.
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