Daratumumab (Darzalex)

General information

Class/mechanism: Anti-CD38 antibody, human monoclonal IgG1 kappa. Daratumumab binds to CD38 and causes apoptosis in CD38-expressing cells via Fc mediated cross-linking, complement-dependent cytotoxicity (CDC), antibody-dependent cell mediated cytotoxicity (ADCC), and antibody dependent cellular phagocytosis (ADCP). CD38 is present on the cell surface of multiple myeloma (MM), plasma leukemia, and natural killer (NK) cells.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Multiple myeloma

Patient drug information

• Daratumumab (Darzalex) package insert
• Daratumumab (Darzalex) patient drug information (Chemocare)
• Daratumumab (Darzalex) patient drug information (UpToDate)

History of changes in FDA indication

• 11/16/2015: Granted FDA accelerated approval "for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent."
• 11/21/2016: FDA approved "in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy."

Also known as

HuMax-CD38, JNJ-54767414, DARA