Daratumumab Overview

Introduction of Daratumumab

Daratumumab, a novel therapeutic human IgG1κ monoclonal antibody with high-affinity against the unique CD38 epitope, is an anti-cancer drug used in combination with other antineoplastic agents in the therapy of multiple myeloma. It was generated by the immunization of transgenic mice possessing the human immunoglobulin gene with recombinant CD38 protein and NIH 3T3 (expressing human CD38) cells until CD38-specific serum titer development. Under the brand name DARZALEX™ by Janssen Biotech, daratumumab was granted approval by the U.S. Food and Drug Administration for treatment of multiple myeloma in patients who had received at least three prior therapies including bortezomib, lenalidomide and pomalidomide. And it was also conditionally approved for treatment of multiple myeloma in Europe, Canada, Japan, and Australia.

Mechanism of Action of Daratumumab

The therapeutic effects of daratumumab in multiple myeloma are mainly based on the mechanism that daratumumab binds to CD38 expressed on the surface of multiple myeloma cells to induce rapid cell death of multiple myeloma cells through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), apoptosis upon secondary crosslinking, and immunomodulatory effects via a decrease in immune suppressive cells (Fig. 1).

Fig.1 Mechanism of Action of Daratumumab

Clinical Projects of Daratumumab*

Approved Drugs of Daratumumab**

INN (trade name)	Therapeutic area	Dosage	Strength	Route	Company	Marketing start	Market
Darzalex	Multiple Myeloma	Injection, solution, concentrate	20 mg/ml	Intravenous	Janssen Biotech, Inc.	2015-11-16
Darzalex	Multiple Myeloma	Injection, solution, concentrate	20 mg/ml	Intravenous	Janssen Cilag International Nv	2016-05-20
Darzalex	Multiple Myeloma	Injection, solution, concentrate	20 mg/ml	Intravenous	Janssen Pharmaceuticals	2016-07-12
Darzalex	Multiple Myeloma	Injection, solution, concentrate	20 mg/ml	Intravenous	Janssen-Cilag Pty Ltd	2017-07-17

INN, International nonproprietary name.

What We Provide

Recombinant Antibody

Mouse Anti-Daratumumab Recombinant Antibody

We provide high-quality mouse anti-daratumumab recombinant antibody for use in ELISA, Block and most other immunological methods. For lab research use only, not for diagnostic, therapeutic or any in vivo human use.

Resources
* The table was excerpted from the following website
https://clinicaltrials.gov/ct2/results?cond=&term=daratumumab

** Information presented in the table was collected from the following websites:
https://www.drugbank.ca/drugs/DB09331
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004077/human_med_001979.jsp
http://search.tga.gov.au/s/search.html?collection=tga-artg&profile=record&meta_i=281843

For research use only. Not intended for any clinical use.