FDA approves Darzalex Faspro for MM

The US Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) 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.

Darzalex Faspro was developed and is marketed by Janssen, the pharmaceutical arm of US healthcare giant Johnson & Johnson (NYSE: JNJ).

Efficacy was evaluated in APOLLO (NCT03180736), an open-label, active-controlled trial with 304 patients randomized (1:1) to Darzalex Faspro with pomalidomide and dexamethasone (Pd) versus Pd alone. Patients received Darzalex Faspro 1,800mg/30,000 units (1,800mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously once weekly from Weeks 1 to 8, once every two weeks from Weeks 9 to 24 and once every four3  weeks starting with Week 25 until disease progression or unacceptable toxicity with pomalidomide 4mg once daily orally on days 1-21 of each 28-day cycle; and dexamethasone 40mg per week (or a reduced dose of 20mg per week for patients >75 years).