Osimertinib (Tagrisso) for the treatment of advanced lung cancer with activating EGFR mutations


Osimertinib (trade name: Tagrisso) has been approved in Germany since March 2018 for the treatment of advanced lung cancer with activating mutations of the epidermal growth factor receptor (EGFR). The drug can be used in adult patients who have cancer cells with particular mutations that can lead to faster tumor growth.

Osimertinib (trade name: Tagrisso) has already been approved in Germany since March 2016 for the treatment of advanced lung cancer with a T790M mutation of the epidermal growth factor receptor (EGFR). Learn more about advantages and disadvantages of osimertinib for this group of people here.

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

  • small-cell lung cancer (SCLC) and
  • non-small-cell lung cancer (NSCLC).

NSCLC is surgically removed. 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.

Mutations of the growth factor

Some people with non-small-cell lung cancer have an abnormal protein in the tumor tissue, called epidermal growth factor receptor (EGFR). It can occur in various forms (mutations). Activating EGFR mutations include the mutations exon 21 and exon 19. Activating EGFR mutations can permanently send out growth signals, contributing to the uncontrolled growth of the tumor.

Osimertinib aims to block the mutated receptor in patients who have an activating EGFR mutation in particular, in order to inhibit further tumor growth.


Osimertinib is taken once a day in tablet form. The drug is available in two different doses: 40 and 80 mg. The recommended dosage is 80 mg per day.

The dosage depends on how well the patient tolerates the drug, as well as on the side effects, and can be adjusted individually. The treatment is stopped if the disease still progresses or if very severe side effects arise.

Other treatments

For adults with activating EGFR mutations who have not had treatment before, the standard treatment is afatinib, erlotinib or gefitinib.


In 2018 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether osimertinib has any advantages or disadvantages for adults with activating EGFR mutations compared with the standard treatments.

In 2018, the manufacturer provided one study involving a total of 556 patients with an EGFR exon 21 or exon 19 mutation. 279 of them had treatment with osimertinib. Of the remaining 277, 183 received gefitinib and 94 received erlotinib. From the study, early estimates can be inferred for the entire group of patients.

What are the advantages of osimertinib?

  • Life expectancy: Here, early estimates suggest an advantage of osimertinib when compared with the standard treatment. After an average observation period of around 18 months, about 21 out of 100 participants who had treatment with osimertinib had passed away. During the same time period, about 30 out of 100 patients who had a standard treatment had passed away.
  • Severe side effects: According to preliminary estimates, severe side effects were less common in men who took osimertinib than in men who had a standard treatment. 29 out of 100 men who used osimertinib had severe side effects, while with the standard treatment it was about 51 out of 100 men. For women, there was no real difference between the treatment groups.
  • Treatment stopped due to side effects: Early estimates suggest that osimertinib has an advantage here. About 13 out of 100 people stopped their treatment with osimertinib, compared to about 18 out of 100 people who had a standard treatment.
  • Elevated liver values and severe skin conditions: According to initial estimates, these side effects were less common in patients with osimertinib than with the standard treatments.

What are the disadvantages of osimertinib?

The study did not find that osimertinib had any disadvantages compared with standard treatments.

What remains unanswered?

The study doesn’t include any suitable data concerning the effects of osimertinib on

  • quality of life
  • symptoms of the disease

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 the review and the hearings received, the G-BA passed a resolution on the added benefit of osimertinib (Tagrisso).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Osimertinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-45. October 11, 2018. (IQWiG reports; Volume 674).

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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Created on October 31, 2018

Next planned update: 2021


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

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