DARZALEX FASPRO
DARZALEX FASPRO is a combination of a CD38-directed cytolytic antibody and an endoglycosidase indicated for the treatment of adult patients with multiple myeloma and light chain (AL) amyloidosis. The therapy is used across various stages of multiple myeloma, including newly diagnosed cases in both transplant-eligible and ineligible patients, relapsed or refractory disease, and high-risk smoldering multiple myeloma. It is administered as a monotherapy or in combination with other therapeutic agents such as proteasome inhibitors, immunomodulatory drugs, and corticosteroids.
How DARZALEX FASPRO Works
Daratumumab is a monoclonal antibody that targets CD38, a glycoprotein expressed on the surface of hematopoietic and clonal plasma cells, inducing tumor cell death through direct apoptosis and immune-mediated lysis. These immune-mediated effects include complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis. The hyaluronidase component acts locally to depolymerize hyaluronan in the extracellular matrix, temporarily increasing subcutaneous tissue permeability to facilitate drug delivery. The treatment also reduces specific subsets of CD38-positive suppressor cells and regulatory T and B cells.
Details
- Status
- Prescription
- First Approved
- 2020-05-01
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DARZALEX FASPRO Approval History
What DARZALEX FASPRO Treats
1 indicationsDARZALEX FASPRO is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
DARZALEX FASPRO Target & Pathway
ProTarget
A protein highly expressed on multiple myeloma cells. Anti-CD38 antibodies target and kill myeloma cells through multiple mechanisms, becoming a backbone of myeloma treatment across disease stages.
DARZALEX FASPRO Competitors
Pro2 other drugs also target CD38. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD38). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DARZALEX FASPRO FDA Label Details
ProIndications & Usage
FDA Label (PDF)DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, melphalan and pre...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.