FDA Approves Daratumumab and Hyaluronidase-fihj Combination Therapy for Multiple Myeloma
Posted: Friday, July 16, 2021
On July 9, the U.S. Food and Drug Administration (FDA) approved the use of the CD38-directed antibody daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who received one prior line of therapy, including lenalidomide and a proteasome inhibitor.
The recommended dosage of Darzalex Faspro is 1,800 mg/30,000 units (1,800 mg of daratumumab and 30,000 units of hyaluronidase) administered subcutaneously into the abdomen over approximately 3 to 5 minutes, according to the recommended schedule. For more prescribing information visit, accessdata.fda.gov.
The FDA approval is based on the multicenter, open-label, phase III APOLLO clinical trial. The study evaluated daratumumab and hyaluronidase-fihj in combination with pomalidomide and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in 304 patients with relapsed or refractory multiple myeloma. Patients had received at least one prior treatment regimen, received both lenalidomide and a proteasome inhibitor, and demonstrated disease progression.
The APOLLO study met its primary endpoint of improved progression-free survival. Results showed daratumumab and hyaluronidase-fihj significantly reduced the risk of disease progression or death by 37% compared with pomalidomide and dexamethasone (P = .0018). The median progression-free survival for daratumumab and hyaluronidase-fihj was 12.4 vs. 6.9 months, respectively.
The daratumumab and hyaluronidase-fihj group compared with the pomalidomide and dexamethasone group had a higher overall response rate (69% vs. 46%), a higher complete response or better rate (25% vs. 4%), and a very good partial response or better rate (51% vs. 20%). Additionally, minimal residual disease negativity was observed in more patients administered daratumumab and hyaluronidase-fihj than given pomalidomide and dexamethasone alone (9% vs. 2%).
The most common adverse events observed in 20% or more of patients given daratumumab and hyaluronidase-fihj included fatigue, pneumonia, upper respiratory tract infection, and diarrhea.
