On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro®) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
Efficacy was evaluated in an open-label, active-controlled trial (APOLLO, NCT03180736), with 304 patients randomized 1:1 to receive daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone (Pd) versus Pd alone. Patients received daratumumab and hyaluronidase-fihj 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously once weekly from weeks 1–8, once every two weeks from weeks 9–24, and once every four weeks starting with week 25 until they experienced disease progression or unacceptable toxicity. They also received pomalidomide 4 mg once daily orally on days 1–21 of each 28-day cycle and dexamethasone 40 mg per week (or a reduced dose of 20 mg per week for patients older than 75).
The main efficacy outcome measure was progression-free survival (PFS). The median PFS was 12.4 months in the daratumumab and hyaluronidase-fihj–Pd treatment group and 6.9 months in the Pd treatment group (HR = 0.63; 95% CI = 0.47, 0.85; p = 0.0018), representing a 37% reduction in the risk of disease progression or death.
The most common adverse reactions (≥ 20%) in patients with multiple myeloma who received daratumumab and hyaluronidase-fihj–Pd are fatigue, pneumonia, upper respiratory tract infection, and diarrhea.
The recommended dosage of daratumumab and hyaluronidase-fihj is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately three to five minutes according to the recommended schedule.
View full prescribing information for daratumumab and hyaluronidase-fihj.
The review used Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment. FDA approved the application two months ahead of FDA’s goal date.
Healthcare professionals should report all serious adverse events they suspect are associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.