Ipilimumab (Yervoy) for the treatment of melanoma

Introduction

The drug ipilimumab (trade name: Yervoy) has been approved in Germany since July 2011 for the treatment of advanced melanoma in adults. Since May 2018, ipilimumab has also been approved in combination with the drug nivolumab. And since January 2018, it has also been approved for teenagers over the age of 12.

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 they are sometimes too large to be removed or may have spread to other parts of the body (metastasized) through the blood or lymphatic system. If this happens, it is called advanced melanoma.

Ipilimumab is used to treat advanced melanoma that can no longer be surgically removed or that has already spread to other parts of the body. The aim of treatment with this drug is to stimulate the to fight the cancer.

Application

Ipilimumab is given as an infusion (IV drip), entering the bloodstream directly through a vein. The infusion takes about 90 minutes. The exact dose will depend on the patient's body weight. The entire treatment with ipilimumab takes 12 weeks, during which the drug is given four times at intervals of three weeks.

Other treatments

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

  • The first-line treatment options include vemurafenib, cobimetinib, dabrafenib, trametinib, nivolumab and pembrolizumab.
  • Subsequent treatment can be individually tailored by a doctor. This treatment will depend on which treatments have been tried before.

For teenagers, treatment can also be individually tailored by a doctor.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether people with advanced melanoma can benefit from treatment with ipilimumab.

The manufacturer did not provide any suitable studies regarding teenagers.

The manufacturer provided suitable studies for the following groups:

  • Ipilimumab alone for adults who have had treatment before
  • Ipilimumab in combination with nivolumab for adults who have not had treatment before and who don't have a BRAF V600 mutation

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 ipilimumab (Yervoy) in first-line and subsequent treatment for teenagers and adults, and in combination with nivolumab (Opdivo).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ipilimumab – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A12-07. April 27, 2012. (IQWiG reports; Volume 130).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ipilimumab (new therapeutic indication) – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission: A13-44. March 13, 2014. (IQWiG reports; Volume 209).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Addendum to Commission A13-44 (Ipilimumab, new therapeutic indication). Commission A14-11. March 26, 2014. (IQWiG reports; Volume 213).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). 2. Addendum to Commission A13-44 (Ipilimumab, new therapeutic indication). CommissionA14-15. May 16, 2014. (IQWiG reports; Volume 223).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ipilimumab (melanoma) – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A18-12. May 09, 2018. (IQWiG reports; Volume 626).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ipilimumab (melanoma) – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A18-44. September 27, 2018. (IQWiG reports; Volume 669).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on May 30, 2018
Next planned update: 2021

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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