(Multiple Myeloma) FDA Approves Darzalex Faspro (Daratumumab + Hyaluronidase) with Pomalidomide and Dexamethasone
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
- 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.
Multiple Myeloma | Daratumumab | Darzalex Faspro | FDA Approval
-
Clinical Trial Medications
- (Lung Cancer) Phase II results for Topotecan and Topotecan + Berzosertib combination.
- (Lung Cancer) Efficacy of Trastuzumab deruxtecan in HER2-mutant non-small cell lung cancer (NSCLC).
- (Lung Cancer) Clinical outcomes of anti-B7-H3 antibody-drug conjugate DS-7300.
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Considering medical care in Japan? Need information and support?
We help you organize the information needed for medical travel to Japan, liaise with Japanese medical institutions, and arrange a second-opinion consultation.The first consultation is free (initial direction only; further services are quoted separately); an advisor will help you clarify the next steps.
Figure 1
Figure 2
Figure 3
Figure 4