Darzalex Approval History
- FDA approved: Yes (First approved November 16th, 2015)
- Brand name: Darzalex
- Generic name: daratumumab
- Dosage form: Injection
- Company: Janssen Biotech, Inc.
- Treatment for: Multiple Myeloma
Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.
Darzalex binds with high affinity to the transmembrane ectoenzyme CD38 on the surface of multiple myeloma cells. It works by inducing rapid tumor cell death.
Darzalex is administered via intravenous infusion. Patients are given antihistamine, antipyretic, and corticosteroid medicines before each dose, and corticosteroids after each dose to reduce the risk of infusion reactions.
Darzalex may cause serious reactions, including infusion reactions. The most common side effects reported in clinical studies were fatigue, nausea, back pain, pyrexia, cough, and upper respiratory tract infection.
Development History and FDA Approval Process for Darzalex
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