FDA Approves Subcutaneous Daratumumab Combo Regimen for Second-Line Multiple Myeloma


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; = .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.”


  1. 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. News release. The Janssen Pharmaceutical Companies of Johnson & Johnson. July 12, 2021. Accessed July 12, 2021. https://bit.ly/3k7AOIu
  2. Dimopoulos MA, Terpos E, Boccadoro M, et al. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(6):801-812. doi:10.1016/S1470-2045(21)00128-5

This article was originally published on OncLive as “FDA Approves Subcutaneous Daratumumab Plus Pd for Multiple Myeloma at First or Subsequent Relapse”

© 2024 MJH Life Sciences

All rights reserved.