Darzalex (daratumumab)

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Darzalex (daratumumab)

How to buy Darzalex: You can order Darzalex (daratumumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Janssen Biotech
Disease Blood Cancer
Indication Multiple myeloma
Mode of Action Monoclonal antibody (immunotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 945721-28-8
HS Code 29334990
Strength 20 mg/mL

Who is daratumumab for?

Daratumumab is indicated 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 [1][2][8]; or as second line treatment of multiple myeloma in combination with other medicines, namely lenalidomide and dexamethasone, or bortezomib and dexamethasone [1][3][8].

Recommended dose

Complete information about daratumumab dosage and administration can be found here [1][3].
The recommended dose is 16 mg/kg body weight according to the following schedule.
As monotherapy and in combination with lenalidomide and low-dose dexamethasone:
  • weekly infusions for week 1–8 (total of 8 infusions)
  • from week 9–24 every 2 weeks (total of 8 infusions)
  • from week 25 onwards until disease progression every four weeks [1][3].
In combination with bortezomib and dexamethasone:
  • weekly infusions for week 1–9 (total of 9 infusions)
  • from week 10–24 every 3 weeks (total of 5 infusions)
  • from week 25 onwards until disease progression every four weeks [1].
Consult your treating doctor for personalised dosing.

What is daratumumab and how does it work?

Daratumumab is a human CD38-directed monoclonal antibody indicated 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 [1].
Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, producing an abnormal protein and pushing out other healthy blood cells from the bone marrow [4]. Daratumumab is a monoclonal antibody that works by helping certain cells in the immune system attack these cancer cells [4]. One of the antigens expressed on the surface of multiple myeloma cells is called CD38. Anti-CD38 antibodies, like daratumumab, target multiple myeloma cells by binding to the CD38 antigen and then signaling the patient’s immune system to attack the tumour [5].

What is daratumumab approval status?

Darzalex (daratumumab) was approved by:
  • FDA (USA) on November 16, 2015 [4]
  • EMA (EU) on May 20, 2016 [2]
  • TGA (AUS) on July 17, 2017 [8]
for multiple myeloma as monotherapy, for the treatment of patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent [3][4][8]. Daratumumab is also indicated as second-line treatment in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone [1][3][7][8].
The approvals of daratumumab as monotherapy were partly based on two studies that returned positive results. In study MMY2002 31 of the 106 patients treated with daratumumab experienced a complete or partial reduction in their tumour burden (overall response rate (ORR) = 29.2 %; 95 % confidence interval (CI) 20.8, 38.9), which lasted for an average of 7.4 months [6][1][3]. The median overall survival (OS) was 17.5 months [3]. The second study (GEN501), involving 42 participants, resulted in a complete or partial reduction of the tumour for 36 % of the patients. The median duration of response was not reached and after 15.2 months 74 % of the patients were still alive [3].
The approval of daratumumab in combination with lenalidomide and dexamethasone was based on a study which compared treatment with daratumumab in combination with lenalidomide and dexamethasone (DLD) (N = 286) to lenalidomide and dexamethasone (LD) alone (N = 283) in 569 patients with multiple myeloma who had received at least one prior treatment. The OS in the DLD was 91.3 % vs 74.6 %. The median progression free survival (mPFS) was 18.4 months in the LD group while it was not reached in the DLD arm. The risk of disease progression or death in the DLD group was reduced by 63% in the DLD arm compared to the LD arm [1].
The approval of daratumumab in combination with bortezomib and dexamethasone was based on a study which compared treatment with daratumumab in combination with bortezomib and dexamethasone (DBD) (N = 251) to bortezomib and dexamethasone (BD) alone (N = 247) in 498 patients with multiple myeloma who had received a median of 2 prior treatments. The mPFS was 7.2 months in the BD group while it was not reached in the DBD arm. The risk of disease progression or death in the BD group was reduced by 61% in the DBD arm compared to the BD arm [1].
References
[1] Summary of Product Characteristics: Darzalex (daratumumab), Janssen Biotech Inc, FDA, Nov. 2016.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf
[2] EMA. Human Medicines: Darzalex (daratumumab), 27/05/2016 (last update: 02/06/2017), cited on 18/01/2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004077/human_med_001979.jsp&mid=WC0b01ac058001d124
[3] Summary of Product Characteristics: Darzalex (daratumumab), Janssen-Cilag International, EMA, July 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004077/WC500207296.pdf
[4] FDA News Release: FDA approves Darzalex for patients with previously treated multiple myeloma, 16/11/2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472875.htm
[5] Helwick C., Strong Showing for Anti-CD38 Antibodies in Multiple Myeloma. The ASCO Post. 10/02/2015.
http://www.ascopost.com/issues/february-10,-2015/strong-showing-for-anti-cd38-antibodies-in-multiple-myeloma.aspx
[6] Lional S., et al. Phase II study of daratumumab (DARA) monotherapy in patients with ≥ 3 lines of prior therapy or double refractory multiple myeloma (MM): 54767414MMY2002 (Sirius). J Clin Oncol. 2015 Jun. 2; 33
http://meetinglibrary.asco.org/content/150339-156
[7] European Commission grants expanded label for Darzalex. The pharma letter. 29/04/2017.
https://www.thepharmaletter.com/article/european-commission-grants-expanded-label-for-darzalex
[8] TGA. Public Summary: Darzalex (daratumumab).
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=9791BBA782AF92C3CA258160004211C7&agid=(PrintDetailsPublic)&actionid=1








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