Imlygic

talimogene laherparepvec

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This is a summary of the European public assessment report (EPAR) for Imlygic. 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 Imlygic.

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

What is Imlygic and what is it used for?

Imlygic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that cannot be surgically removed and that has spread to other parts of the body (but not to bone, lung, brain and other internal organs).

Imlygic is a type of advanced therapy medicine called a ‘gene therapy product’. This is a type of medicine that works by delivering genes into the cells of the body. It contains the active substance talimogene laherparepvec.

How is Imlygic used?

Treatment with Imlygic should be started and given under the supervision of a doctor with expertise in the treatment of cancer.

Imlygic is available as a solution for injection in two different strengths. It is given as an injection into melanoma tumours. The first dose is given using the lower strength of Imlygic, but subsequent doses use the higher strength. The second dose is given three weeks after the first dose and treatment is continued every two weeks for at least six months, unless the doctor considers that the patient is not benefiting from the medicine. The volume to be injected depends on the size of the tumour and the number of tumours to be injected. For more information, see the summary of product characteristics (also part of the EPAR).

How does Imlygic work?

The active substance in Imlygic, talimogene laherparepvec, is a type of gene therapy called ‘oncolytic virus’. It is derived from a weakened herpes simplex virus 1 (the cold sore virus). This virus has been modified so it can infect and multiply inside melanoma cells. Imlygic uses the melanoma cells’ own machinery to multiply, eventually overwhelming melanoma cells and killing them. Although Imlygic can enter healthy cells, it is not designed to multiply inside them.

In addition, Imlygic makes the infected melanoma cells produce a protein called GM-CSF. This protein stimulates the patient’s immune system (the body’s natural defences) to recognise and destroy melanoma cells.

What benefits of Imlygic have been shown in studies?

Imlygic has been studied in one main study involving 436 patients with inoperable melanoma that had spread to other parts of the body (but not to bone and brain). The study, which lasted 24 months, compared Imlygic with GM-CSF injected under the skin. The main measure of effectiveness was the proportion of patients who responded to treatment and for whom the response lasted for at least six months before the patients’ health declined or they required another therapy. Response to treatment was defined as reduction by at least 50% in the signs of melanoma.

When looking at the subset of patients in the study (249 patients) whose disease had not spread to the lung or other internal organs, 25% (41 out of 163) of patients treated with Imlygic had a sustained response to treatment, compared with around 1% (1 out of 86) of patients treated with GM-CSF.

What are the risks associated with Imlygic?

The most common side effects with Imlygic (which may affect more than 1 in 4 people) are tiredness, chills, pyrexia (fever), nausea (feeling sick), flu-like illness and pain at the injection site. Most of these side effects were mild or moderate in severity. The most common serious side effect (affecting around 2 in 100 people) was cellulitis (infection of the upper layers of the skin). Because Imlygic contains a herpes virus, it may reactivate at a later time causing herpes infections such as cold sores. In patients whose immune system is weak (e.g. patients with HIV), Imlygic may cause more widespread disease. Imlygic must not be used in patients with a severely impaired immune system because if the virus gets reactivated, the herpes infection could spread to other parts of the body. For the full list of all side effects and restrictions reported with Imlygic, see the package leaflet.

Why is Imlygic approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Imlygic is a therapy with a novel mechanism of action which can be a valuable addition to existing therapies for advanced inoperable melanoma, an area of unmet medical need. Patients with inoperable melanoma which had spread to other parts of the body (but not to bone, brain or lung) showed a prolonged reduction in their melanoma tumours when treated with Imlygic, although it is still not known whether this will translate into longer survival. Regarding safety, Imlygic was relatively well tolerated and most side effects were mild or moderate in severity. Thus, CHMP decided that Imlygic’s benefits are greater than its risks and recommended that it be approved for use in the EU.

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

A risk management plan has been developed to ensure that Imlygic 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 Imlygic, including the appropriate precautions to be followed by healthcare professionals and patients.

The company has put in place a controlled distribution programme to qualified centres to ensure that the cold storage and handling requirements are observed and to control the distribution to the patients. As part of this programme, the medicine will only be supplied to doctors who have received appropriate educational materials on the risk of herpes infection, particularly in patients with an impaired immune system, on the risk of transmission of the virus to healthcare professionals or other close contacts of the patient (accidental exposure), and on the necessary precautions to be taken when administering and disposing of the product. Patients will also be provided with educational materials and a patient alert card informing on the risks with the medicine and how to avoid accidental exposure to Imlygic.

The company will also carry out three studies to further characterise the benefits and risks of Imlygic, including a study of Imlygic in patients with advanced melanoma that can be surgically removed.

Further information can be found in the summary of the risk management plan.

Other information about Imlygic

The European Commission granted a marketing authorisation valid throughout the European Union for Imlygic on 16 December 2015.

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

Name Language First published Last updated
Imlygic : EPAR - Summary for the public BG = bălgarski 2016-02-05  
Imlygic : EPAR - Summary for the public ES = español 2016-02-05  
Imlygic : EPAR - Summary for the public CS = čeština 2016-02-05  
Imlygic : EPAR - Summary for the public DA = dansk 2016-02-05  
Imlygic : EPAR - Summary for the public DE = Deutsch 2016-02-05  
Imlygic : EPAR - Summary for the public ET = eesti keel 2016-02-05  
Imlygic : EPAR - Summary for the public EL = elliniká 2016-02-05  
Imlygic : EPAR - Summary for the public EN = English 2016-02-05  
Imlygic : EPAR - Summary for the public FR = français 2016-02-05  
Imlygic : EPAR - Summary for the public IT = italiano 2016-02-05  
Imlygic : EPAR - Summary for the public LV = latviešu valoda 2016-02-05  
Imlygic : EPAR - Summary for the public LT = lietuvių kalba 2016-02-05  
Imlygic : EPAR - Summary for the public HU = magyar 2016-02-05  
Imlygic : EPAR - Summary for the public MT = Malti 2016-02-05  
Imlygic : EPAR - Summary for the public NL = Nederlands 2016-02-05  
Imlygic : EPAR - Summary for the public PL = polski 2016-02-05  
Imlygic : EPAR - Summary for the public PT = português 2016-02-05  
Imlygic : EPAR - Summary for the public RO = română 2016-02-05  
Imlygic : EPAR - Summary for the public SK = slovenčina 2016-02-05  
Imlygic : EPAR - Summary for the public SL = slovenščina 2016-02-05  
Imlygic : EPAR - Summary for the public FI = suomi 2016-02-05  
Imlygic : EPAR - Summary for the public SV = svenska 2016-02-05  
Imlygic : EPAR - Summary for the public HR = Hrvatski 2016-02-05  
Name Language First published Last updated
Imlygic : EPAR - Risk-management-plan summary (English only) 2016-02-05  

This EPAR was last updated on 07/09/2016 .

Authorisation details

Product details

Product details for Imlygic
NameImlygic
Agency product numberEMEA/H/C/002771
Active substance

talimogene laherparepvec

International non-proprietary name (INN) or common name

talimogene laherparepvec

Therapeutic area Melanoma
Anatomical therapeutic chemical (ATC) code L01
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.

Publication details

Publication details for Imlygic
Marketing-authorisation holder

Amgen Europe B.V.

Revision1
Date of issue of marketing authorisation valid throughout the European Union16/12/2015

Contact address:

Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
Netherlands

Product information

Product information

23/07/2016  Imlygic -EMEA/H/C/002771 -IB/0001/G

Name Language First published Last updated
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07
Imlygic : EPAR - Product Information EN = English 2016-02-05 2016-09-07

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
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  
Imlygic : EPAR - All Authorised presentations EN = English 2016-02-05  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Imlygic : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-09-07  

Initial marketing-authorisation documents

Name Language First published Last updated
Imlygic : EPAR - Public assessment report EN = English 2016-02-05  
CHMP summary of opinion for Imlygic EN = English 2015-10-23