FDA Approves Daratumumab, Hyalyronidase-fihj in Combination With Pomalidomide, Dexamethasone for Multiple Myeloma


Results from the APOLLO trial showed a significant 37% reduction in the risk of progression or death, compared to pomalidomide and dexamethasone alone in patients with multiple myeloma.

Officials with the FDA have approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma following their first or subsequent relapse.

This marks the sixth indication for daratumumab and hyaluronidase-fihj and follows Janssen’s FDA submission in November 2020. The approval is based on findings from the phase 3 APOLLO study, according to a press release.

Multiple myeloma is an incurable blood cancer that impacts plasma cells. When damaged, these cells spread rapidly and replace normal cells with tumors in the blood marrow. According to the press release, an estimated 34,000 people will be diagnosed with multiple myeloma in 2021 and close to 12,500 will die from the disease in the United States.

The study met its primary endpoint of improved progression-free survival (PFS), with a significant 37% reduction in the risk of progression or death compared to pomalidomide and dexamethasone alone. The median progression-free survival (PFS) for the arm receiving daratumumab and hyaluronidase-fihj was 12.4 months, compared to 6.9 months in the control arm.

“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, principal investigator and chairman of the department of clinical therapeutics at the National and Kapodistrian University of Athens School of Medicine, in the 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 house needed for intravenous administration.”

In addition to the PFS results, the APOLLO findings showed that the rate of overall response was significantly higher in the daratumumab and hyalronidase-fihj arm compared to the control arm (69% versus 46%). Rates of complete response were also significantly higher, at 25% in the investigational arm and 4% in the control arm.

Similarly, very good partial responses were seen in 51% of the daratumumab-based arm and 20% in the control arm. Additionally, 9% of patients treated with daratumumab and hyaluronidase-fihj showed a negative status for minimal residual disease compared to 2% of patients receiving pomalidomide and dexamethasone alone.

Two percent of patients in the investigational arm discontinued treatment permanently due to an adverse event (AE), according to the press release, although no AEs resulting in permanent discontinuation occurred in more than 1 patient. The most common AEs were fatigue, pneumonia, upper respiratory tract infection, and diarrhea. Serious AEs occurred in 50% of patients who received daratumumab and hyaluronidase-fihj and included pneumonia and lower respiratory tract infection. Fatal AEs occurred in 7% of patients in the investigational arm.

“Today’s approval further distinguishes Darzalex Faspro in the treatment of multiple myeloma as the first and only subcutaneously administered anti-CD38 monoclonal antibody approved in combination with the widely used pomalidomide and dexamethasone regimen,” said Craig Tendler, MD, vice president of late development and global medical affairs at Janssen Research & Development, LLC, in the press release.


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. Janssen. July 12, 2021. Accessed July 12, 2021. https://www.janssen.com/janssen-announces-us-fda-approval-darzalex-faspror-daratumumab-and-hyaluronidase-fihj-combination

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