The drug nivolumab (trade name: Opdivo) has been approved in Germany since July 2015 for the treatment of advanced lung cancer. It is an option for adults with advanced non-small cell cancer who have already had chemotherapy.

Lung cancer is caused by the growth of malignant cells in the airways (bronchi) and their branches (bronchioles). It is also referred to as bronchogenic carcinoma. There are two main types of tumors:

  • Small cell lung cancer, SCLC
  • Non-small cell lung cancer, NSCLC

Depending on the result of a tissue examination, non-small cell carcinomas are classified into these groups:

  • Squamous cell carcinoma
  • Adenocarcinoma
  • Large cell carcinoma

Non-small cell carcinoma is surgically removed, if possible. But sometimes the tumor has already become too large or the cancer has spread to other parts of the body (metastasis) through the blood or lymphatic system. This is called advanced lung cancer.

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


Nivolumab enters the bloodstream directly through a vein infusion (an IV drip). This infusion takes about 60 minutes and is given every two weeks. The exact dose is determined by body weight.

Treatment is stopped if it is no longer tolerated or the disease gets worse.

Other treatments

The standard therapy option for patients with advanced squamous cell carcinoma who have already had platinum-based chemotherapy is the drug docetaxel. If docetaxel is not tolerated, the aim is to relieve symptoms such as pain, and improve quality of life tailored to the patient's individual needs. This kind of therapy is known as "best supportive care" (BSC).

The drugs docetaxel, pemetrexed, gefitinib, erlotinib and crizotinib are options for patients with advanced adenocarcinoma or large cell lung carcinoma who have already had treatment, depending on health status, pretreatment and characteristics of the tumor. If these treatments are not possible, they can receive supportive care.


In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether people with advanced non-small cell lung cancer can benefit from treatment with nivolumab.

The manufacturer provided two studies comparing nivolumab and docetaxel. So it was not possible to tell whether nivolumab has any advantages or disadvantages compared with pemetrexed, gefitinib, erlotinib, crizotinib or BSC. The following results only apply to the comparison of nivolumab and docetaxel.

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More information

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