The drug pembrolizumab (trade name: Keytruda) has been approved in Germany since July 2016 for the treatment of advanced non-small-cell lung cancer. It can be used in adult patients who have mutated cancer cells that can lead to faster tumor growth.

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

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

NSCLC 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. It is then called advanced lung cancer.

Pembrolizumab has been approved for use in people who have a tumor with elevated levels of the protein PD-L1. This protein weakens the body's immune response, particularly the activity of T cells, against the tumor cells.

Those who are affected might also have a mutated receptor in the tumor tissue called an epidermal growth factor receptor (EGFR). And the tumor cells may produce a specific enzyme called anaplastic lymphoma kinase (ALK). Both of these changes cause further uncontrolled tumor growth as well. Pembrolizumab is also an option for this group of people if earlier treatments for EGFR or the enzyme ALK have been unsuccessful.

Pembrolizumab blocks the effect of the PD-L1 protein produced by the tumor tissue and initiates an immune response to the cancer cells in order to inhibit tumor growth.


Pembrolizumab comes in the form of a powder that is dissolved in a liquid and then given through an infusion (an IV drip), entering the bloodstream directly through a vein. The infusion is given every three weeks and lasts about 30 minutes each time. The dose will depend on the patient's body weight. This treatment is discontinued if severe side effects occur or if the cancer continues to grow.

Other treatments

The following treatments are available for people with advanced lung cancer and the PD-L1 mutation:

  • As first-line treatment for a tumor without mutated EGFR or ALK, depending on general health and the side effects, the options are either platinum-based chemotherapy (using drugs such as cisplatin or carboplatin combined with vinorelbine, gemcitabine, docetaxel, paclitaxel or pemetrexed) or treatment with gemcitabine or vinorelbine.
  • As second-line treatment, if previous chemotherapy was unsuccessful, the standard approach is treatment with docetaxel, pemetrexed or nivolumab. These standard treatments are also an option for adults with an additional EGFR or ALK mutation who have previously had unsuccessful therapy. If none of these standard treatments are possible, best supportive care (BSC) is used. BSC should be tailored to the patient's individual needs, relieve pain and other symptoms, and improve quality of life.


In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of pembrolizumab for people with advanced lung cancer and a PD-L1 mutation compared to the standard therapies so far.

The manufacturer provided two relevant studies for the following groups:

  • Pembrolizumab as a first-line treatment for people with advanced lung cancer
  • Pembrolizumab as a second-line treatment for people with advanced lung cancer

Learn more

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 pembrolizumab (Keytruda).