Opdivo (nivolumab)

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Opdivo (nivolumab)

How to buy Opdivo (nivolumab): You can order Opdivo (nivolumab) 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 Urothelial Carcinoma, Colorectal Cancer, Head and Neck Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Lymphoma, Skin Cancer
Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG
Mode of Action Monoclonal antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Therapeutic Goods Administration (TGA), Australia
Strength 10 milligram / millilitre
Package 1 Vials

What is Opdivo (nivolumab) for?

Opdivo (nivolumab) is indicated for the treatment of patients with:

  • metastatic melanoma as a single agent or in combination with ipilimumab1,2,3,4

  • metastatic non-small cell lung cancer (NSCLC) whose cancer progressed on or after chemotherapy1,2,3,5

  • advanced renal cell carcinoma who have received prior anti-angiogenic therapy1,2

  • classical Hodgkin lymphoma that has relapsed or progressed after other treatments1

  • recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or within 6 months of receiving platinum-based chemotherapy1

  • locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy10

  • microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan13

  • hepatocellular carcinoma in patients who have been previously treated with sorafenib1,14 

How does Opdivo (nivolumab) work?

Opdivo (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 cells6.

Is Opdivo (nivolumab) approved?

Opdivo (nivolumab) was approved by

  • FDA (USA)
    • on December 22, 2014, for unresectable or metastatic melanoma11
    • on March 4, 2015, for metastatic squamous non-small cell lung cancer (NSCLC)11
    • on November 23, 2015, for advanced renal cell carcinoma11
    • 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 carcinoma10
    • on August 1, 2017, for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer13
    • on September 22, 2017, for hepatocellular carcinoma (HCC) following prior  treatment with sorafenib14
    • on December 20, 2017, for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection15
  • EMA (EU)
    • on June 19, 2015, for metastatic melanoma6
    • on July 20, 2015, for NSCLC6
    • on February 26, 2016, for advanced renal cell carcinoma12
    • on October 13, 2016, for relapsed or refractory cHL6
    • on June 2, 2017, for urothelial carcinoma6
  • TGA (Australia)
    • on January 11, 2016, for the metastatic melanoma and NSCLC3, and later for advanced clear cell renal cell and relapsed or refractory cHL.
  • PMDA (Japan)
    • on June 2014 for unresectable malignant melanoma4
    • on December 17, 2015, for NSCLC5
    • on August 5, 2016, for unresectable or metastatic renal cell carcinoma5 
    • on October 17, 2016, for relapsed or refractory classical Hodgkin lymphoma16 
    • on February 22, 2017, for recurrent or distant metastatic head and neck cancer17  
    • on August 22, 2017, for unresectable advanced or recurrent gastric cancer that has progressed after cancer chemotherapy18.

How do I take Opdivo (nivolumab)?

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 in the official prescribing information listed in our resources section1,2,3.

Note: Consult your treating doctor for personalised dosing.

Are there any known adverse reactions of Opdivo (nivolumab)?

Common adverse reactions

The most common adverse reactions were1:
  • fatigue
  • rash
  • musculoskeletal pain
  • diarrhoea
  • nausea.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2,3.

More Information
Working ingredient Nivolumab
Shipping method Cold chain (temperature controlled)
Length (cm) 6
Width (cm) 4
Height (cm) 10
Package 1
Therapeutic Area Oncology
Oncology Urothelial Carcinoma, Colorectal Cancer, Head and Neck Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Lymphoma, Skin Cancer
Indication Relapsed or refractory classical Hodgkin lymphoma
Indication Hepatocellular carcinoma previously treated with sorafenib, Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC)
Indication recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Indication Non-Small Cell Lung Cancer (NSCLC)
Indication Metastatic melanoma
Indication Advanced renal cell carcinoma, Locally advanced or metastatic urothelial carcinoma
Administration Intravenous
Mode of Action Monoclonal antibody (immunotherapy)
Strength 10
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG
Opdivo's (nivolumab) approvals were based on several studies.

The efficacy of Opdivo (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 paclitaxel6. 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 worsening6.

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 treatments6.

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 months6.

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 months8.

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 docetaxel9.

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 months10.

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 months13.

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 longer1.

1. Summary of Product Characteristics [FDA]: Opdivo (nivolumab) [PDF]
    Bristol-Myers Squibb, Mar. 2018.

2. Summary of Product Characteristics [EMA]: Opdivo (nivolumab)
    Bristol-Myers Squibb Pharma EEIG, Mar. 2017

3. Summary of Product Characteristics [TGA]: Opdivo (nivolumab)
    Bristol-Myers Squibb Australia Pty Ltd, May 2017

4. Report on deliberation results (Japan) [PDF]
    PMDA.go.jp, June 2014

5. Report on deliberation results (Japan) [PDF]
    PMDA.go.jp, August 2016

6. Human Medicines: Opdivo (nivolumab)
    EMA, cited Sept 2015

7. 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
    Weber J.S., et al. The Lancet Oncology, April 2015

8. Approved Drugs: Nivolumab (Opdivo) for Hodgkin Lymphoma
    FDA, May 2016

9. Approved Drugs: Nivolumab for SCCHN
    FDA, Nov 2016 

10. FDA Approves Nivolumab for Urothelial Carcinoma
      OncLive, Feb 2017

11. Opdivo Approval History
      Drugs.com, cited May 2016

12. EMA Press Release. New treatment for advanced form of kidney cancer
      EMA, Feb 2016 

13. Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment
     Drugs.com, Aug 2017

14.FDA Approves Nivolumab for Hepatocellular Carcinoma
     Onclive, Sept 2017

15.FDA grants regular approval to nivolumab for adjuvant treatment of melanoma
     FDA, Dec 2017 

16. Report on deliberation results (Japan) [PDF]
      PMDA.go.jp, October 2016.

17. Report on deliberation results (Japan) [PDF]
      PMDA.go.jp, February 2017.

18. Report on deliberation results (Japan) [PDF]
      PMDA.go.jp, August 2017.

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
Length (cm) 6
Width (cm) 4
Height (cm) 10
This content has been reviewed by our medical doctor Jan de Witt.

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