Opdivo (nivolumab)

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Opdivo (nivolumab)

How to buy Opdivo: You can order Opdivo (nivolumab) 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 Colorectal Cancer / Head and Neck Cancer / Hodgkin Lymphoma / Kidney Cancer / Lung Cancer / Skin Cancer / Bladder Cancer / Liver Cancer
Indication Melanoma; Head and Neck Squamous Cell Carcinoma (HNSCC); Classical Hodgkin Lymphoma (cHL); Advanced (metastatic) colorectal cancer; Non-Small Cell Lung Cancer (NSCLC); Metastatic Renal Cell Carcinoma; Urothelial Carcinoma; Hepatocellular Carcinoma
Mode of Action Monoclonal antibody (immunotherapy)
Approval Status EMA approved (EU); FDA approved (USA); PMDA approved (JAP); TGA approved (AUS)
CAS Number 9046114-94-4
HS Code 30049000
Strength 10 mg/mL

Who is nivolumab for?

Nivolumab is indicated for the treatment of patients with:
  • metastatic melanoma as single agent or in combination with ipilimumab [1][2][3][4]
  • metastatic non-small cell lung cancer (NSCLC) whose cancer progressed on or after chemotherapy [1][2][3][5]
  • advanced renal cell carcinoma who have received prior anti-angiogenic therapy [1][2]
  • classical Hodgkin lymphoma that has relapsed or progressed after other treatments [1]
  • recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or within 6 months of receiving platinum-based chemotherapy [1]
  • locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy [10]
  • microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan [13]
  • hepatocellular carcinoma in patients who have been previously treated with sorafenib [1][14]

Recommended dose

The recommended therapy varies for the different indications and depends on whether nivolumab is used alone or in combination with other therapeutics. Complete information about nivolumab dosage and administration for some of the countries of approval can be found at the following links: [1][2][3].

Consult your treating doctor for personalised dosing.

What is nivolumab and how does it work?

Nivolumab is a monoclonal antibody—a type of protein that has been designed to recognise and attach to a specific structure, found in certain cells in the body. Nivolumab has been designed to attach to a receptor called PD-1, found on certain cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor, switching off the T cells. By attaching to the receptor, nivolumab prevents cancer cells from switching off T cells, thereby increasing the ability of the immune system to kill cancer cells [6].
What is nivolumab's approval status?

Nivolumab was approved by
  • FDA (USA)
    • on December 22, 2014, for unresectable or metastatic melanoma [11]
    • on March 4, 2015, for metastatic squamous non-small cell lung cancer (NSCLC) [11]
    • on November 23, 2015, for advanced renal cell carcinoma [11]
    • on May 17, 2016, for classical Hodgkin lymphoma (cHL) [11]
    • on November 10, 2016, for head and neck squamous cell carcinoma (HNSCC) [11]
    • on February 2, 2017, for advanced unresectable or metastatic urothelial carcinoma [10].
    • on August 1, 2017, for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer [13]
    • on September 22, 2017, for hepatocellular carcinoma (HCC) following prior  treatment with sorafenib [14]
  • EMA (EU)
    • on June 19, 2015, for metastatic melanoma [6]
    • on July 20, 2015, for NSCLC [6]
    • on February 26, 2016, for advanced renal cell carcinoma [12]
    • on October 13, 2016, for relapsed or refractory cHL [6].
  • TGA (Australia)
    • on January 11, 2016, for the metastatic melanoma and NSCLC [3], and later for advanced clear cell renal cell and relapsed or refractory cHL.
  • PMDA (Japan)
    • on June 2014 for unresectable malignant melanoma [4]
    • on December 17, 2015, for NSCLC [5].
Nivolumab's approvals were based on several studies.
The efficacy of nivolumab on metastatic melanoma as single therapy emerged from two main studies in patients with advanced disease. The first study involving 418 previously untreated advanced melanoma patients found that patients treated with nivolumab survived longer than patients who received the cancer medicine dacarbazine: 73 % of patients treated with nivolumab were alive at 12 months compared with 42 % of patients given dacarbazine. The second study looked at 405 advanced melanoma patients whose disease worsened, despite previous treatment with a cancer medicine. In this study, around 32 % (38 out of 120) of patients given nivolumab responded to treatment and had a reduction in their tumours—compared with about 11 % (5 out of 47) of patients given dacarbazine or a combination of carboplatin and paclitaxel [6]. In a phase 3 trial involving 120 patients with unresectable or metastatic melanoma, a reduction in tumour size was observed in 32 % of patients. The most notable observation was that this effect lasted in one-third of the patients (a durable response) [7]. An additional study involving 945 previously untreated advanced melanoma patients investigated nivolumab in combination with ipilimumab; nivolumab used alone and ipilimumab used alone. Patients who were given nivolumab plus ipilimumab lived for another 11.5 months without their disease worsening; patients who were given only nivolumab lived for another 6.9 months without their disease worsening. Patients given only ipilimumab lived for only 2.9 months without their disease worsening [6].
The efficacy of nivolumab on NSCLC, both squamous and non-squamous, has been shown in comparison with another cancer medicine named docetaxel. For non-squamous NSCLC, one main study involved 582 patients whose disease had progressed despite previous treatments. The average survival with nivolumab was around 12.2 months, compared with 9.4 months with docetaxel. For squamous NSCLC, a study involving 272 patients showed that patients who were given nivolumab survived for around 9.2 months, compared with 6.0 months with patients given docetaxel. Supportive information was also provided from another study indicating that Opdivo could produce a response in patients with squamous NSCLC whose disease had progressed despite several previous treatments [6].
The efficacy of nivolumab on renal carcinoma was based on an open-label randomised study of 821 patients with advanced renal cell carcinoma. Patients treated with nivolumab showed an overall survival of 25 months, as compared to patients treated with everolimus, with an overall survival 19.6 months [6].
The efficacy of nivolumab on classical Hodgkin lymphoma (cHL) was based on two single-arm, multicentre trials of nivolumab in adults with relapsed or refractory cHL. Efficacy was evaluated in 95 patients previously treated with autologous HSCT and post-transplantation brentuximab vedotin. Single-agent nivolumab produced a 65 % objective response rate (ORR) (95 % CI: 55 %, 75 %), with 58 % partial remission and 7 % complete remission. The median time-to-response was 2.1 months (range: 0.7 to 5.7 months). The estimated median duration of response (DOR) was 8.7 months [8].
The efficacy of nivolumab on HNSCC was based on a study that enrolled 361 patients. It resulted that the overall survival was 7.5 months for patients treated with nivolumab and 5.1 months for patients treated with either cetuximab, methotrexate, or docetaxel [9].
The efficacy of nivolumab on urothelial carcinoma was based on a study that enrolled 270 patients with platinum-refractory metastatic urothelial carcinoma. The objective response rate (ORR) was 19.6 % while the complete response rate was 3%. The median progression-free survival (PFS) was 2.0 months and the median overall survival (OS) was 8.74 months [10].
The efficacy of nivolumab on colorectal cancer was based on a study that enrolled 74 patients. Of these 32 % (95 % CI: 22-44; 24/74) responded to treatment with 2.7 % (2/74) complete responses and 30 % (22/74) partial responses. Among the 74 patients, 53 received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. In this group 28 % of the patients responded to treatment with nivolumab, 1.9 % had a complete response was (1/53) and 26 % had a partial response (14/53). Among these responders, the median duration of response was not reached and it ranged between 2.8 to 22.1 months [13].

The efficacy of nivolumab on hepatocellular carcinoma was based on a study that enrolled 154 patients who progressed on or were intolerant to sorafenib (a chemotherapy). According to the Response Evaluation Criteria In Solid Tumors (RECIST) 14.3 % (95 % CI: 9.2, 20.8) of the patients responded to the treatment with 1.9 % complete responses. The duration of response ranged from 3.2 months to over 38.2 months, with 55  % of those patients having responses of 12 months or longer [1].
The most common adverse reactions were: fatigue, rash, musculoskeletal pain, diarrhea, and nausea [1].
References
[1] Summary of Product Characteristics [FDA]: Opdivo (nivolumab), Bristol-Myers Squibb, Sep. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s041lbl.pdf
[2] Summary of Product Characteristics [EMA]: Opdivo (nivolumab), Bristol-Myers Squibb Pharma EEIG, Mar. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003985/WC500189765.pdf
[3] Summary of Product Characteristics [TGA]: Opdivo (nivolumab), Bristol-Myers Squibb Australia Pty Ltd, May 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-01052-1&d=2017061216114622483
[4] Report on deliberation results (Japan). 24/06/2014.
http://www.pmda.go.jp/files/000209430.pdf
[5] ONO Pharmaceuticals Press Release. ONO receives manufacturing and marketing approval partial amendment approval for OPDIVO® (generic name: nivolumab) for treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer in Japan, 17/12/2015.
https://www.ono.co.jp/eng/news/pdf/sm_cn151217.pdf
[6] EMA. Human Medicines: Opdivo (nivolumab), 16/07/2015 (last update: 14/03/2017), cited on 30/09/2015.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003985/human_med_001876.jsp&mid=WC0b01ac058001d124
[7] Weber J.S., et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. The Lancet Oncology. 2015 Apr; 16 (4): 375–384.
http://www.sciencedirect.com/science/article/pii/S1470204515700768
[8] FDA. Approved Drugs: Nivolumab (Opdivo) for Hodgkin Lymphoma. 17/05/2016.
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm501412.htm
[9] FDA. Approved Drugs: Nivolumab for SCCHN. 10/11/2016.
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm528920.htm
[10] FDA Approves Nivolumab for Urothelial Carcinoma. OncLive. 02/02/2017.
http://www.onclive.com/web-exclusives/fda-approves-nivolumab-for-urothelial-carcinoma
[11] Drugs.com. Opdivo Approval History. Cited on 18/05/2016.
https://www.drugs.com/history/opdivo.html
[12] EMA Press Release. New treatment for advanced form of kidney cancer, 26/02/2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/02/news_detail_002478.jsp&mid=WC0b01ac058004d5c1
[13] Drugs.com. Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment, 01/08/2017.
https://www.drugs.com/newdrugs/bristol-myers-squibb-receives-fda-approval-opdivo-nivolumab-msi-h-dmmr-metastatic-colorectal-cancer-4566.html
[14] Onclive. FDA Approves Nivolumab for Hepatocellular Carcinoma, 22/09/2017.
http://www.onclive.com/web-exclusives/fda-approves-nivolumab-for-hepatocellular-carcinoma









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