Introduction

Nivolumab (trade name: Opdivo) has been approved in Germany since June 2015 for the treatment of advanced melanoma in adults. Since May 2016, nivolumab has also been approved for adults with advanced melanoma in combination with the drug ipilimumab.

Since August 2018, nivolumab may also be used as supportive (adjuvant) treatment after the surgical removal of melanoma if the cancer had spread to lymph nodes or to other parts of the body (metastasis).

Melanoma is the most dangerous type of skin cancer. It starts growing in the cells that produce the dark pigment in skin. Melanomas are usually surgically removed. But sometimes they may have already spread to lymph nodes, neighboring tissue or other parts of the body. The aim of adjuvant treatment is to kill any remaining tumor cells in the body to prevent a recurrence.

If the tumor has grown too large to be removed or if it has formed distant metastases, it is called advanced melanoma.

The aim of treatment with this drug is to stimulate the immune system to fight the cancer.

Application

Nivolumab for the treatment of advanced melanoma

Depending on whether nivolumab is used alone or in combination with ipilimumab, the drug is given every two, three or four weeks as an intravenous infusion (IV drip) into the bloodstream. One infusion lasts 30 to 60 minutes.

The treatment is terminated if the disease progresses or if very severe side effects arise.

Nivolumab as adjuvant treatment

When used in adjuvant treatment, nivolumab is given every two weeks as an infusion. The recommended dose will depend on the patient's body weight. One infusion lasts about an hour.

The treatment continues for up to a year.

Other treatments

Patients with advanced melanoma have several treatment options. The options depend on whether they have had treatment before and whether they have a mutated protein in the tumor tissue (BRAF V600 mutation). This protein can lead to uncontrolled tumor growth.

  • For patients who have had previous treatment, the therapy options depend on things like which drug had been used before. The treatment is individually adjusted by their doctor.
  • If it is their first treatment and they have a BRAF V600 mutation, vemurafenib is an option.
  • If it is their first treatment and they do not have a BRAF V600 mutation, pembrolizumab or nivolumab alone are options.

After surgical removal of melanoma that had already spread to the lymph nodes or other parts of the body, the standard treatment is watchful waiting: Patients are examined regularly to detect any recurrence early on.

Assessment

Nivolumab for the treatment of advanced melanoma

In 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether nivolumab alone has any advantages or disadvantages for people with advanced melanoma when compared with dacarbazine – the standard treatment at the time. On the basis of those results, nivolumab became the new standard treatment for people without a BRAF V600 mutation.

In 2017 and 2018, the manufacturer provided study results which compared the combination of nivolumab plus ipilimumab with nivolumab alone for the treatment of advanced melanoma. In this study too, only people without a BRAF V600 mutation participated.

Nivolumab as adjuvant treatment

In 2018, IQWiG looked into whether adjuvant treatment with nivolumab has any advantages or disadvantages compared with the standard treatment for people after surgical removal of melanoma which had spread to lymph nodes or other parts of the body.

But the manufacturer didn’t provide any suitable data with which to do the assessment. So it remains unclear whether adjuvant treatment with nivolumab has any advantages or disadvantages after the surgical removal of advanced melanoma.

 

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More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of nivolumab (Opdivo).