Drug profile·Last updated June 15, 2025

Darzalex (daratumumab)

Reference profile of daratumumab (Darzalex): anti-CD38 monoclonal antibody in multiple myeloma per FDA records.

This is a verified reference page — not a flagship Humanexa Review essay. Claims are sourced from structured evidence and updated on a reference schedule.

Drug overview

Daratumumab, marketed as Darzalex, is a human IgG1 monoclonal antibody targeting CD38 on plasma cells. Janssen (Johnson & Johnson) markets daratumumab in combinations documented across FDA approval histories for multiple myeloma and light chain amyloidosis.

Indication areas

Newly diagnosed multiple myeloma — transplant-eligible and ineligible regimens per FDA label.
Relapsed/refractory multiple myeloma — multiple combination approvals in FDA records.
Light chain amyloidosis indication documented in Drugs@FDA.

Competitive context

Daratumumab competes within multiple myeloma with other CD38-directed agents, proteasome inhibitors, IMiDs, and BCMA-targeted therapies documented in FDA databases and trial registries. Sequencing decisions are trial- and label-driven.

Regulatory and clinical milestones

Initial accelerated approval pathway history documented in FDA records.
Series of combination regimen approvals across lines of therapy.
Subcutaneous formulation (Darzalex Faspro) approvals in FDA databases.

Sources

FDA Drugs@FDA databaseRegulatory communication · January 1, 2024
ClinicalTrials.govClinical trial registry · January 1, 2024
SEC EDGAR company filingsCompany filing · January 1, 2024

Drug overview

Indication areas

Competitive context

Regulatory and clinical milestones

Sources

Reference pages