FDA approves daratumumab and hyaluronidase-fihj for sixth multiple myeloma indication

Last week saw the FDA approval of 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.1

Subcutaneous daratumumab has been shown to offer benefits compared to the intravenous (IV) formulation. Subcutaneously administered daratumumab was found to provide a similar safety and pharmacokinetic profile and lower infusion-related reactions compared to the IV formulation. Additionally, the subcutaneous formulation has been demonstrated to provide deep and durable responses in patients with heavily pre-treated myeloma.2

The open-label APOLLO trial (NCT03180736) randomized (1:1) 304 patients to daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone (Pd) vs. Pd alone.  

Meletios A. Dimopoulos, MD, Principal Investigator and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicines spoke with us on APOLLO during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020. Watch the full interview below:

The primary efficacy endpoint in this study was progression-free survival (PFS). The median PFS was 12.4 months in the daratumumab and hyaluronidase-fihj treatment arm and 6.9 months in the Pd treatment arm (HR 0.63; 95% CI: 0.47, 0.85; p=0.0018), representing a 37% decrease in disease progression or death risk for patients treated with daratumumab and hyaluronidase-fihj versus Pd alone.

According to the recommended schedule, 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.1

  1. U.S Food and Drug Administration. FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-pomalidomide-and-dexamethasone-multiple-myeloma (last accessed 14/07/2021).
  2. Usmani SZ, Nahi N, Mateous MV et al. Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. Blood. 2019 Aug 22;134(8): 668–677.

Written by Thomas Southgate