Lutathera

lutetium (177Lu) oxodotreotide

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

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

What is Lutathera and what is it used for?

Lutathera is a cancer medicine for treating tumours in the gut known as gastroenteropancreatic neuroendocrine tumours (GEP‑NETs). It is a radiopharmaceutical (a medicine that emits a small amount of radioactivity).

Lutathera is used is to treat GEP-NETs that cannot be removed by surgery, have spread to other parts of the body or are not responding to treatment.

The medicine is only for GEP‑NETs that have receptors called somatostatin receptors on their cell surfaces.

Because the number of patients with GEP‑NETs is low, they are considered ‘rare’, and Lutathera was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 31 January 2008.

Lutathera contains the active substance lutetium (177Lu) oxodotreotide.

How is Lutathera used?

Because Lutathera emits some radioactivity, it is only used in special controlled areas and must be handled and given to patients by qualified personnel. The patient cannot leave the controlled areas until told to do so by the doctor.

Before starting treatment, the doctor will have checked that the patient’s tumours have somatostatin receptors on their cell surfaces. Lutathera is given by infusion (drip) into a vein. The usual treatment involves 4 infusions 8 weeks apart, but the gap between infusions can be increased to up to 16 weeks if the patient gets severe side effects. The patient should also be given an infusion of an amino acid solution which helps protect their kidneys.

For further information, including information on the precise method for giving the infusions, see the package leaflet.

How does Lutathera work?

The active substance in Lutathera, lutetium (177Lu) oxodotreotide, works by attaching to somatostatin receptors, which are found in high numbers in some GEP‑NETs. The radioactivity it emits then kills the tumour cells it is attached to but has little effect on neighbouring cells.

What benefits of Lutathera have been shown in studies?

Lutathera can help slow down the worsening of GEP‑NETs. In a main study of 229 patients with GEP‑NETs that contained somatostatin receptors, patients given Lutathera lived for an average of 28 months without their disease getting worse. This compares with around 9 months for patients treated with octreotide, a medicine already approved for treating the condition.

What are the risks associated with Lutathera?

The most common side effects seen with Lutathera treatment are nausea and vomiting, which occurred at the start of the infusions in around half of patients and may be related to the amino acid infusion. Other common side effects affecting more than 1 in 10 patients are thrombocytopenia (low platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia (low red cell counts), pancytopenia (low levels of all types of blood cells), tiredness and reduced appetite. For the full list of all side effects reported with Lutathera, see the package leaflet.

Lutathera must not be given to women who are pregnant or in whom pregnancy has not been excluded. It must also not be given to patients with severely reduced kidney function. For the full list of restrictions, see the package leaflet.

Why is Lutathera approved?

Only a minority of patients with GEP‑NETs can be cured with surgery and at the time of diagnosis the tumours would have spread in most patients. Lutathera can help slow the worsening of the condition and its side effects are considered manageable.

The European Medicines Agency considered that the benefits seen with Lutathera outweigh its risks and recommended it be approved in the EU.

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

The company that markets Lutathera will put in place an educational programme for patients to ensure they understand the risk of radioactivity and precautions they should take to limit exposure to themselves and people around them.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lutathera have also been included in the summary of product characteristics and the package leaflet.

Other information about Lutathera

The European Commission granted a marketing authorisation valid throughout the European Union for Lutathera on 26 September 2017.

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

Name Language First published Last updated
Lutathera : EPAR - Summary for the public BG = bălgarski 2018-01-17  
Lutathera : EPAR - Summary for the public ES = español 2018-01-17  
Lutathera : EPAR - Summary for the public CS = čeština 2018-01-17  
Lutathera : EPAR - Summary for the public DA = dansk 2018-01-17  
Lutathera : EPAR - Summary for the public DE = Deutsch 2018-01-17  
Lutathera : EPAR - Summary for the public ET = eesti keel 2018-01-17  
Lutathera : EPAR - Summary for the public EL = elliniká 2018-01-17  
Lutathera : EPAR - Summary for the public EN = English 2018-01-17  
Lutathera : EPAR - Summary for the public FR = français 2018-01-17  
Lutathera : EPAR - Summary for the public IT = italiano 2018-01-17  
Lutathera : EPAR - Summary for the public LV = latviešu valoda 2018-01-17  
Lutathera : EPAR - Summary for the public LT = lietuvių kalba 2018-01-17  
Lutathera : EPAR - Summary for the public HU = magyar 2018-01-17  
Lutathera : EPAR - Summary for the public MT = Malti 2018-01-17  
Lutathera : EPAR - Summary for the public NL = Nederlands 2018-01-17  
Lutathera : EPAR - Summary for the public PL = polski 2018-01-17  
Lutathera : EPAR - Summary for the public PT = português 2018-01-17  
Lutathera : EPAR - Summary for the public RO = română 2018-01-17  
Lutathera : EPAR - Summary for the public SK = slovenčina 2018-01-17  
Lutathera : EPAR - Summary for the public SL = slovenščina 2018-01-17  
Lutathera : EPAR - Summary for the public FI = suomi 2018-01-17  
Lutathera : EPAR - Summary for the public SV = svenska 2018-01-17  
Lutathera : EPAR - Summary for the public HR = Hrvatski 2018-01-17  

This EPAR was last updated on 17/01/2018 .

Authorisation details

Product details

Product details for Lutathera
NameLutathera
Agency product numberEMEA/H/C/004123
Active substance

lutetium (177Lu) oxodotreotide

International non-proprietary name (INN) or common name

lutetium (177Lu) oxodotreotide

Therapeutic area Neuroendocrine Tumors
Anatomical therapeutic chemical (ATC) code V10XX04
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Lutathera
Marketing-authorisation holder

Advanced Accelerator Applications

Revision0
Date of issue of marketing authorisation valid throughout the European Union26/09/2017

Contact address:

Advanced Accelerator Applications
20 rue Diesel 
01630 Saint Genis Pouilly
France

Product information

Product information

26/09/2017  Lutathera -EMEA/H/C/004123 --

Name Language First published Last updated
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  
Lutathera : EPAR - Product Information HR = Hrvatski 2018-01-17  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Lutathera : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  

Pharmacotherapeutic group

Other therapeutic radiopharmaceuticals

Therapeutic indication

Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP‑NETs) in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Lutathera : EPAR - Public assessment report HR = Hrvatski 2018-01-17  
CHMP summary of positive opinion for Lutathera HR = Hrvatski 2017-07-21  

Authorised

This medicine is approved for use in the European Union

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