Daratumumab: A Comprehensive Monograph on a First-in-Class Anti-CD38 Monoclonal Antibody

I. Introduction and Drug Profile

A. Overview of Daratumumab

Daratumumab is a first-in-class, human-specific, CD38-directed cytolytic monoclonal antibody that has fundamentally altered the treatment landscape for hematological malignancies, most notably multiple myeloma (MM) and light chain (AL) amyloidosis.[1] Classified as a protein-based therapy and antineoplastic agent, it functions by targeting the CD38 protein, which is highly and uniformly expressed on the surface of malignant plasma cells.[1] This targeted immunotherapy represents a significant departure from traditional cytotoxic chemotherapy, leveraging the patient's own immune system to eradicate cancer cells.

The medication is commercially available under two principal brand names: Darzalex®, the original formulation for intravenous (IV) infusion, and Darzalex Faspro®, a subsequent subcutaneous (SC) formulation that is co-formulated with the enzyme hyaluronidase-fihj to facilitate rapid administration.[1] The introduction of daratumumab marked a major milestone in the field, as it was the first monoclonal antibody approved to specifically target the CD38 antigen in multiple myeloma, providing a novel mechanism of action for a disease characterized by recurrent relapse and eventual resistance to other therapies.[5]

B. Development and Commercialization