August 2021: Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) have been approved by the Food and Drug Administration in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy that included lenalidomide and a proteasome inhibitor.
In APOLLO (NCT03180736), 304 patients were randomised (1:1) to Darzalex Faspro with pomalidomide and dexamethasone (Pd) against Pd alone in an open-label, active-controlled trial. Patients were given Darzalex Faspro 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) 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, along with pomalidomide 4 mg once daily orally on days 1-21 of each 28-day cycle; and dexamethasone 40 mg once daily or
The primary effectiveness metric was progression-free survival (PFS). The median PFS in the Darzalex Faspro-Pd therapy group was 12.4 months compared to 6.9 months in the Pd treatment group (HR 0.63; 95 percent CI: 0.47, 0.85; p=0.0018), indicating a 37 percent lower risk of disease progression or mortality in patients treated with Darzalex Faspro-Pd versus Pd.
Fatigue, pneumonia, upper respiratory tract infection, and diarrhoea are the most prevalent adverse events in individuals with multiple myeloma who received Darzalex Faspro-Pd (20%).
Darzalex Faspro’s recommended dosage is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) injected subcutaneously into the abdomen over 3 to 5 minutes according to the manufacturer’s instructions.
Reference: https://www.fda.gov/
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