Empliciti (elotuzumab)

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Empliciti (elotuzumab)

How to order Empliciti: You can order Empliciti (elotuzumab) 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 Bristol-Myers Squibb
Disease Blood Cancer
Indication Multiple Myeloma
Mode of Action SLAMF7-directed immunostimulatory antibody (immunotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
Strength 300 mg, 400 mg

Who is elotuzumab for?

Elotuzumab is indicated together with two other medicines (lenalidomide and dexamethasone) for the treatment of patients with multiple myeloma who have tried at least 1 [1]to 3 [2]previous cancer treatment(s).

Recommended dose

Complete information about elotuzumab dosage and administration can be found here: [2][3][4].
The standard dosage is:
  • 10 mg/kg administered intravenously every week for the first two cycles (1 cycle = 4 weeks) and every 2 weeks thereafter until disease progression or unacceptable toxicity
  • Administer with lenalidomide and dexamethasone
Consult your treating doctor for personalised dosing.

What is elotuzumab and how does it work?

Elotuzumab is a cancer medicine used in combination with lenalidomide and dexamethasone to treat patients with multiple myeloma who have received one to three prior therapies [2][3][4].
The active substance in Empliciti, elotuzumab, is a monoclonal antibody that activates the body’s immune cells to attack the multiple myeloma cancer cells. It does this by attaching to a protein on the surface of the immune cells called SLAMF7, causing them to act against the cancer cells and thereby slowing down the disease. Elotuzumab also attaches to SLAMF7 on the cancer cells, making them more vulnerable to attack by the immune cells [1].

What is elotuzumab's approval status?

Elotuzumab was approved by:
  • FDA (USA) on November 30, 2015 [5]
  • EMA (EU) on May 11, 2016 [1]
  • TGA (AUS) on September 22, 2016 [4]
for the treatment of multiple myeloma in combination with lenalidomide and dexamethasone as second or fourth line treatment.

The approvals were based on a study (ELOQUENT-2) involving 646 multiple myeloma patients [2][3][4]. The study compared the effects of taking elotuzumab plus lenalidomide and dexamethasone (N = 321) with the effects of taking only lenalidomide and dexamethasone (N = 325) [2][3][4]. Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity. The evaluation was based on two parameters: the progression free survival (PFS) and the overall response rate (ORR). The PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease where it does not get worse [6]. The ORR is the portion of patients with a tumour size reduction of a predefined amount for a minimum time period [7].
The median PFS in patients that took elotuzumab in addition to lenalidomide and dexamethasone was 4.2 months longer than in patients who took lenalidomide and dexamethasone only (18.5 months (95 % CI 16.5, 21.4) vs 14.3 months (95% CI 12.0, 16.0)). The 1-year PFS rate — the portion of patients that after 1 year of treatment had no progression of their disease yet — was 68 % of the patients on the elotuzumab addition compared with 56 % of the patients on the other two drugs only. The 2-year PFS rate and the 3-year response rate were 39 % and 23 % for patients with elotuzumab and 26% and 15 % for patients without. The median ORR was 78.5 % (95 % CI 73.6, 82.9) with elotuzumab and 65.5 % (95 % CI 60.1, 70.7) without, with a complete response of 4.4 % vs. 7.4 %. The median overall survival (OS) was 43.7 months with elotuzumab and 39.6 months without [2][3][4].
References
[1] EMA. Human Medicines: Empliciti (elotuzumab), 19/05/2016 (last update: 15/12/2016), cited on 16/03/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003967/human_med_001968.jsp&mid=WC0b01ac058001d124
[2] Summary of Product Characteristics: Empliciti (elotuzumab), Bristol-Myers Squibb, FDA, May 2017.
https://packageinserts.bms.com/pi/pi_empliciti.pdf
[3] Summary of Product Characteristics: Empliciti (elotuzumab), Bristol-Myers Squibb, EMA, Dec 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003967/WC500206673.pdf
[4] Summary of Product Characteristics: Empliciti (elotuzumab), Bristol-Myers Squibb Australia, TGA, Sep 2016.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-02539-1
[5] Drugs.com. Empliciti (elotuzumab), (last update: 14/01/2016), cited on 16/03/2017.
https://www.drugs.com/empliciti.html
[6] NIH National Cancer Institute. NCI Dictionary of Cancer Terms: progression-free survival, cited on 16/03/2017.
https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=44782
[7] Pazdur R., Endpoints for Assessing Drug Activity in Clinical Trials. The Oncologist. 2008 Apr; 13(2):19-21.
http://theoncologist.alphamedpress.org/content/13/suppl_2/19.full.pdf+html









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