(Multiple Myeloma) FDA Approves Darzalex Faspro (Daratumumab + Hyaluronidase) with Pomalidomide and Dexamethasone

• July 9, 2021
• 1 min read

On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

This approval is based on the APOLLO trial (NCT03180736), an open-label, active-controlled trial that randomized 304 patients 1:1 to either the pomalidomide/dexamethasone (Pd) group or the Darzalex Faspro group.

Darzalex Faspro dosing regimen:

• Weeks 1–8: Darzalex Faspro (daratumumab 1,800 mg + hyaluronidase 30,000 units) subcutaneously once weekly
• Weeks 9–24: Once every 2 weeks
• Week 25 onwards: Once every 4 weeks until disease progression or unacceptable toxicity
• Pomalidomide: 4 mg orally once daily on Days 1–21 of a 28-day cycle
• Dexamethasone: 40 mg weekly (reduced to 20 mg for patients ≥76 years)

Results:

• Primary endpoint median PFS: Pd group 6.9 months vs. Darzalex Faspro group 12.4 months
• 37% reduction in disease progression or death risk with Darzalex Faspro

Safety:

Most common adverse events (≥20%) in the Darzalex Faspro group: fatigue, pneumonia, upper respiratory tract infection, and diarrhea.

Recommended dose: Darzalex Faspro 1,800 mg/30,000 units (daratumumab 1,800 mg / hyaluronidase 30,000 units), administered subcutaneously over approximately 3–5 minutes in the abdomen.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-pomalidomide-and-dexamethasone-multiple-myeloma

Multiple Myeloma | Daratumumab | Darzalex Faspro | FDA Approval

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