The FDA approval of daratumumab plus hyaluronidase-fihj (Darzalex Faspro) plus pomalidomide and dexamethasone (Pd) was supported by data from the APOLLO trial.
Adult patients with multiple myeloma who have received at least 1 prior line of therapy, including lenalidomide (Revlimid) and a proteasome inhibitor, are now able to be treated with daratumumab plus hyaluronidase-fihj (Darzalex Faspro) plus pomalidomide and dexamethasone (Pd) following an FDA approval.
The regulatory decision was supported by data from the phase 3 APOLLO trial (NCT01960348), which showed that the combination regimen resulted in a significant reduction in the risk of progression or death compared with Pd alone in this patient population.
The median progression-free survival in the investigative arm was 12.4 months vs 6.9 months in the control arm (HR, 0.63; 95% CI, 0.47-0.85; P = .0018); this translated to a 37% reduction. Moreover, the overall response rate proved to be higher with the addition of daratumumab plus hyaluronidase-fihj to Pd vs Pd alone, at 69% vs 46%, respectively. Complete response rates in the investigative and control arms were 25% vs 4%, respectively, and partial response rates were 51% vs 20%, respectively.
“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,” Meletios A. Dimopoulos, MD, professor and chairman of the 2 Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator, stated in a press release. “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.”
This article was originally published on OncLive as “FDA Approves Subcutaneous Daratumumab Plus Pd for Multiple Myeloma at First or Subsequent Relapse”