Giotrif | European Medicines Agency (EMA)

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Overview

This is a summary of the European public assessment report (EPAR) for Giotrif. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Giotrif.

For practical information about using Giotrif, patients should read the package leaflet or contact their doctor or pharmacist.

Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer. It is used specifically in adults with advanced cancer in the following situations:

when the cancer has a mutation in the gene for a protein called EGFR and has not been previously treated with tyrosine kinase inhibitor medicines.
when the cancer is of a squamous cell type (from cells of the lining of the lungs) and has worsened despite treatment with platinum-based chemotherapy.

Giotrif contains the active substance afatinib.

Treatment with Giotrif should be started and supervised by a doctor experienced in the use of cancer medicines.

Giotrif is available as tablets (20, 30, 40 and 50 mg) and is only available with a prescription. The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects. Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe.

The tablets should be taken without food and no food should be eaten for at least 3 hours before and 1 hour after taking the tablets.

The active substance in Giotrif, afatinib, is an ErbB family blocker. This means that it blocks the action of a group of proteins known as ‘ErbB family’ which are found on the surface of cancer cells and are involved in stimulating the cells to divide. By blocking these proteins, afatinib helps to control cell division and thereby slows down the growth and spread of the non-small cell lung cancer.

EGFR proteins are part of the ErbB family. Lung cancer cells with mutated EGFR proteins are particularly sensitive to afatinib.

Giotrif has been shown to significantly delay disease progression in patients with non-small cell lung cancer.

In a main study in 345 patients with tumours that have mutated EGFR genes, patients treated with Giotrif lived on average for 11 months without their disease getting worse compared with 7 months for patients who were treated with two other cancer medicines, pemetrexed and cisplatin.

In a second study in 795 patients with the squamous cell cancer type, patients treated with Giotrif lived on average for 2.6 months without their disease worsening compared with 1.9 months for patients treated with another cancer medicine, erlotinib.

The most common side effects with Giotrif (which may affect more than 1 in 10 people) are paronychia (nail bed infection), reduced appetite, epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), rash, acneiform dermatitis (acne-like skin conditions), pruritus (itching), and dry skin. For the full list of all side effects and restrictions with Giotrif, see the package leaflet.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Giotrif outweigh its risks and recommended that it be granted marketing authorisation in the EU. The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (how long they lived without the disease getting worse) was a meaningful benefit for patients. In addition, the side effects of the medicine were considered to be manageable and similar to those seen with medicines of the same class.

A risk management plan has been developed to ensure that Giotrif is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Giotrif, including the appropriate precautions to be followed by healthcare professionals and patients.

The European Commission granted a marketing authorisation valid throughout the European Union for Giotrif on 25 September 2013.

For more information about treatment with Giotrif, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

English (EN)
(80.92 KB – PDF)

First published: 16/10/2013Last updated: 24/05/2016

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Product information

English (EN)
(1.07 MB – PDF)

First published: 16/10/2013Last updated: 31/03/2025

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Latest procedure affecting product information:
VR/0000261894

31/03/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(18.02 KB – PDF)

First published: 16/10/2013Last updated: 27/03/2014

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Product details

Name of medicine: Giotrif
Active substance: afatinib
International non-proprietary name (INN) or common name: afatinib
Therapeutic area (MeSH): Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code: L01XE13

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Giotrif as monotherapy is indicated for the treatment of

Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

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Giotrif | European Medicines Agency (EMA)

Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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Giotrif | European Medicines Agency (EMA)

Overview

What is Giotrif and what is it used for?

How is Giotrif used?

How does Giotrif work?

What benefits of Giotrif have been shown in studies?

What are the risks associated with Giotrif?

Why is Giotrif approved?

What measures are being taken to ensure the safe and effective use of Giotrif?

Other information about Giotrif

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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