FDA Approves Monoclonal Antibody for Use in Combination Treatment for Multiple Myeloma

The US Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of multiple myeloma.

Darzalex Faspro-Pd is indicated for “adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor,” according to a press release by The Janssen Pharmaceutical Companies of Johnson & Johnson.

This approval was based on the phase 3 APOLLO study findings published in The Lancet Oncology. According to the study, Darzalex Faspro-Pd reduced risk of progression and death in patients with multiple myeloma by 37% compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval [CI], 0.47-0.85; P=0.0018). Fatigue, pneumonia, upper respiratory tract infection, and diarrhea were the most common adverse reactions (≥20%), and serious adverse reactions occurred in 50% of patients receiving Darzalex Faspro-Pd.

"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,” 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.

Darzalex Faspro is the first subcutaneous anti-CD38 monoclonal antibody approved for treatment with pomalidomide and dexamethasone.

Reference:
PR Newswire. 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://www.prnewswire.com/news-releases/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-301331428.html