Introduction

The combination of the drugs trametinib (trade name: Mekinist) and dabrafenib (trade name: Tafinlar) has been approved in Germany for the treatment of advanced lung cancer since March 2017. They are an option for adult patients who have non-small-cell lung cancer with a certain mutation (BRAF V600 mutation).

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

  • 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.

Some people with advanced non-small-cell lung cancer have a mutated protein in the tumor tissue (BRAF V600 mutation) which can cause uncontrolled tumor growth. Dabrafenib and trametinib aim to block the protein and inhibit tumor growth.

Application

A combination of the two drugs is used for the treatment.

Dabrafenib is taken in the morning and in the evening at a dose of 150 mg. The drug is available in 50 and 75 mg tablets.

2 mg of trametinib are taken once a day in the form of a tablet. It is also available in a 0.5 mg dose.

The dosages of these drugs can be adjusted depending on side effects. The treatment is stopped if the disease progresses or if very severe side effects arise.

Other treatments

Depending on their general health, people who have advanced lung cancer with a BRAF V600 mutation, and have not had treatment, can either have the standard treatment with platinum-based chemotherapy in combination with another cytostatic drug or monotherapy with the drugs gemcitabine or vinorelbine.

If they have had treatment before with a different drug, treatment with the drugs docetaxel, pemetrexed or nivolumab is possible. If this is not an option, best supportive care (BSC) is used. Supportive care should be tailored to the patient's individual needs, relieve symptoms such as pain, and improve quality of life.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of trametinib in combination with dabrafenib when compared with the standard treatments for people with advanced lung cancer and a BRAF V600 mutation. But the manufacturer didn’t provide any suitable data with which to do the assessment.

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 these reviews and the hearings received, the G-BA passed a resolution on the added benefit of dabrafenib (Tafinlar) and trametinib (Mekinist).