Darzalex (daratumumab)

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Darzalex (daratumumab)

How to buy Darzalex (daratumumab): You can order Darzalex (daratumumab) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide.

Oncology Multiple Myeloma
Marketing Authorisation Holder Janssen-Cilag International N.V.
Mode of Action Monoclonal antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 20 milligram / millilitre

What is Darzalex (daratumumab)?

Darzalex (daratumumab) is a human CD38-directed monoclonal antibody used to treat multiple myeloma1,3,8.

Who is Darzalex (daratumumab) for?

Darzalex (daratumumab) is indicated for patients with:

  • newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (first-line treatment). For this indication, it is used in combination with bortezomib, melphalan, and prednisone1.

  • multiple myeloma who have received at least one prior therapy (second-line treatment). For this indication, it is used in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone1,3.

  • multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (third-line treatment). For this indication, it is used in combination with pomalidomide and dexamethasone1.

  • 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 (fourth-line treatment). For this indication, it is used as monotherapy1,3.

How does Darzalex (daratumumab) work?

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 marrow4.

Daratumumab is a monoclonal antibody that works by helping certain cells in the immune system attack these cancer cells4. 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 tumour5.

Where has Darzalex (daratumumab) been approved?

Darzalex (daratumumab) was approved for multiple myeloma by:

  • Food and Drug Administration (FDA), USA: 
    • May 7, 2018, as first-line therapy in combination with bortezomib, melphalan, and prednisone9.
    • November 21, 2016, as second-line therapy in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone9.
    • June 16, 2017, as third-line therapy in combination with pomalidomide and dexamethasone9.
  • November 16, 2015, as fourth-line therapy9.
  • EMA (EU) on May 20, 20162.
  • TGA (AUS) on July 17, 20178.

How is Darzalex (daratumumab) taken?

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 weeks1,3.

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 weeks1.

In combination with bortezomib, melphalan, and prednisone (6-week cycle regimen):

  • weekly infusions for week 1–6 (total of 6 infusions)

  • from week 7–54 every 3 weeks (total of 16 infusions)

  • from week 55 onwards until disease progression every four weeks1


Complete information about daratumumab dosage and administration can be found in the resources section.

Note: Consult your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Darzalex (daratumumab)?

Common adverse reactions

The most common side effects adverse reactions (incidence ≥20%) listed in the prescribing information include1: 

  • infusion reactions
  • neutropenia (low white blood cells count)
  • thrombocytopenia (low blood platelet count)
  • fatigue (tiredness)
  • nausea (feeling sick)
  • diarrhea
  • vomiting
  • muscle spasms
  • back pain
  • pyrexia (fever)
  • cough
  • dyspnea (Shortness of breath)
  • dizziness (feeling of being lightheaded, woozy, or unbalanced)
  • insomnia
  • peripheral edema (accumulation of fluids in the limbs)
  • peripheral sensory neuropathy
  • upper respiratory tract infection.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1

  • infusion reactions
  • neutropenia
  • thrombocytopenia.

Use in a specific population

Darzalex (daratumumab) may cause fetal myeloid or lymphoid-cell depletion and decreased bone density. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Darzalex and any potential adverse effects to the breast-fed child.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,3,8.

More Information
Working ingredient daratumumab
Shipping method Cold chain (temperature controlled)
Therapeutic Area Oncology
Oncology Multiple Myeloma
Indication Multiple myeloma
Administration Intravenous
Mode of Action Monoclonal antibody (immunotherapy)
Strength 20
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Janssen-Cilag International N.V.
HS Code 30021091
CAS Number 945721-28-8

1st-line treatment approval

The Food and Drug Administration (FDA), USA, approval of Darzalex (daratumumab) for multiple myeloma as 1st line treatment was based on one open-label, active-controlled, phase 3 study (ALCYONE (NCT02185479)). This study involved a total of 706 patients with newly diagnosed multiple myeloma. Patients were divided into two groups and took the combination of bortezomib, melphalan, and prednisone with or without the addition of Darzalex (daratumumab). Patients continued treatment until disease progression or unacceptable toxicity1. 

Results

Among the efficacy outcome measures were the overall response and minimal residual disease (MRD)- negativity. MRD is the presence of small numbers of cancerous cells that remain in the patient although there are no signs or symptoms of the disease. MRD is the major cause of relapse.

The study ALCYONE demonstrated an improvement in progression-free survival in the patient group that added Darzalex (daratumumab) to their treatment plan. The reduction of risk of disease progression was 50% in this group.

The overall response was:

  • 90.9% with the addition of daratumumab vs. 73.9% without

    • Complete responses: 24.6% vs. 17.4%.

The MRD-negativity rate was:

  • Over all patients: 22.3% [95% CI: 18, 27] with the addition of daratumumab vs. 6.2% [95% CI: 3.9, 9.2]

  • In patients with complete response: 49.7% [95% CI: 41.4, 58] vs. 25.3% [95% CI: 16.6, 35.7]

2nd-line treatment approval

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 arm1.

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 arm1.

 

3rd-line treatment

The approval of daratumumab as combination treatment with pomalidomide and dexamethasone were based on an open-label trial (EQUULEUS - NCT01998971). This study included 103 patients with multiple myeloma who had received a prior proteasome inhibitor and an immunomodulatory agent. Patients received 16 mg/kg Darzalex (daratumumab) in combination with pomalidomide and low-dose dexamethasone until disease progression1.

Results

Among the  efficacy outcome measures were the overall response rate, the median time to response and the median duration of response1.

The overall response rate was:

  • 59.2% (95% CI: 49.1, 68.8)

    • complete responses: 5.8%

    • very good partial responses: 28.2%.

The median time to response was:

  • 1 month (range: 0.9 to 2.8 months). 

The median duration of response was:

  • 13.6 months (range: 0.9+ to 14.6+ months).

4th-line treatment approval

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 months6,1,3. The median overall survival (OS) was 17.5 months3. 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 alive3.

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.