The Food and Drug Administration (FDA) has approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor.
Darzalex Faspro is a subcutaneous (SC) formulation that contains daratumumab, a CD38-directed cytolytic antibody, with hyaluronidase, an endoglycosidase. The SC formulation is administered over approximately 3 to 5 minutes.
The approval was based on data from the open-label, randomized, active-controlled phase 3 APOLLO trial (ClinicalTrials.gov Identifier: NCT03180736), which compared the efficacy and safety of Darzalex Faspro plus pomalidomide and dexamethasone (Darzalex Faspro-Pd) to pomalidomide and dexamethasone (Pd) alone in 304 patients with multiple myeloma who have received at least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor. The primary endpoint was progression-free survival (PFS).
Findings showed an improvement in PFS in the Darzalex Faspro-Pd treatment group as compared to the Pd treatment group; median PFS was observed to be 12.4 months in the Darzalex Faspro-Pd arm and 6.9 months in the Pd arm (hazard ratio, 0.63 [95% CI, 0.47-0.85]; P =.0018), representing a 37% reduction in the risk of disease progression or death for patients treated with Darzalex Faspro-Pd compared with Pd alone. Additionally, the rate of overall response was found to be significantly higher in the Darzalex Faspro-Pd treatment arm compared with the Pd arm (68.9% vs 46.4%; P <.0001). Treatment with Darzalex Faspro-Pd was also associated with a significantly higher MRD negativity rate (8.6% vs 2% for Pd; P =.0102).
“Clinical studies including APOLLO have continued to show the ability of daratumumab-based combination treatment regimens to significantly reduce the risk of progression in patients with multiple myeloma,” said Meletios A. Dimopoulos, MD, Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator. “With this approval, we are now able to combine pomalidomide and dexamethasone with a daratumumab subcutaneous option that can be administered in minutes rather than the hours needed for intravenous administration.”
Darzalex Faspro is supplied as single-dose vials containing 1800mg daratumumab and 30,000 units hyaluronidase per 15mL.
- Halozyme announces Janssen receives US FDA approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for patients with multiple myeloma after first or subsequent relapse. [press release]. San Diego, CA: Halozyme Therapeutics, Inc.; July 12, 2021.
- Janssen announces US FDA approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for patients with multiple myeloma after first or subsequent relapse. [press release]. Horsham, PA: Janssen Pharmaceutical Companies; July 12, 2021.
- Darzalex Faspro [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2021.