Portrazza

necitumumab

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

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

What is Portrazza and what is it used for?

Portrazza is a medicine for treating advanced stages of a type of lung cancer known as squamous non-small cell lung cancer.

Portrazza is only used in adults whose cancer cells have a specific protein (EGFR) on their surface and it is used together with gemcitabine and cisplatin chemotherapy.

Portrazza contains the active substance necitumumab.

How is Portrazza used?

Portrazza is given as a one hour infusion (drip) into a vein. The recommended dose is 800 mg on days 1 and 8 of each 3-week cycle. For the first 6 cycles, Portrazza is given together with gemcitabine and cisplatin chemotherapy, after which it is given on its own for as long the disease remains stable and the patient can tolerate it.

During infusions, resources should be available to deal with reactions that may occur. In case of a severe infusion or skin reaction, treatment may have to be stopped permanently. The risk of reactions can be reduced by adjusting the dose or infusion rate or by using preventive medicines. For more information, see the summary of product characteristics (also part of the EPAR).

Portrazza is available as a concentrate for making a solution and can only be obtained with a prescription.

How does Portrazza work?

The active substance in Portrazza, necitumumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to EGFR on the surface of the cancer cells. EGFR normally controls the growth and division of cells, but in cancer cells EGFR is often overactive, causing them to divide uncontrollably. By attaching to and blocking EGFR, necitumumab helps to reduce the growth and spread of the cancer.

What benefits of Portrazza have been shown in studies?

A main study of 1,093 patients with advanced squamous non-small cell lung cancer showed that adding Portrazza to gemcitabine and cisplatin chemotherapy can lead to a modest improvement in survival. In this study, patients treated with Portrazza in addition to chemotherapy lived on average 1.6 months longer than those treated with chemotherapy alone (11.5 months versus 9.9 months).

Most of the patients (95%) had cancer cells with EGFR. There was no improved survival in patients with non-EGFR cancer cells.

What are the risks associated with Portrazza?

The most common side effects with Portrazza (which may affect more than 1 in 10 people) are skin reactions, vomiting, stomatitis (inflammation of the lining of the mouth), fever, weight loss and low blood measurements of various minerals (magnesium, calcium, phosphate and potassium). The most common serious side effects are severe skin reactions (6% of patients) and blood clots (4% of patients). For the full list of all side effects reported with Portrazza, see the package leaflet.

Portrazza must not be used in patients who have had a severe or life-threatening reaction to any of the ingredients of the medicine.

Why is Portrazza approved?

In the main study, adding Portrazza to gemcitabine and cisplatin chemotherapy improved survival by a modest one and a half months without causing significant worsening in overall patient health. The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Portrazza’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 Portrazza?

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

In addition, the company that markets the medicine will provide doctors with educational material with information on risk of blood clots and on the small number of cardiac arrest cases seen in studies.

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

Other information about Portrazza

The European Commission granted a marketing authorisation valid throughout the European Union for Portrazza on 15 February 2016.

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

Name Language First published Last updated
Portrazza : EPAR - Summary for the public BG = bălgarski 2016-03-04  
Portrazza : EPAR - Summary for the public ES = español 2016-03-04  
Portrazza : EPAR - Summary for the public CS = čeština 2016-03-04  
Portrazza : EPAR - Summary for the public DA = dansk 2016-03-04  
Portrazza : EPAR - Summary for the public DE = Deutsch 2016-03-04  
Portrazza : EPAR - Summary for the public ET = eesti keel 2016-03-04  
Portrazza : EPAR - Summary for the public EL = elliniká 2016-03-04  
Portrazza : EPAR - Summary for the public EN = English 2016-03-04  
Portrazza : EPAR - Summary for the public FR = français 2016-03-04  
Portrazza : EPAR - Summary for the public IT = italiano 2016-03-04  
Portrazza : EPAR - Summary for the public LV = latviešu valoda 2016-03-04  
Portrazza : EPAR - Summary for the public LT = lietuvių kalba 2016-03-04  
Portrazza : EPAR - Summary for the public HU = magyar 2016-03-04  
Portrazza : EPAR - Summary for the public MT = Malti 2016-03-04  
Portrazza : EPAR - Summary for the public NL = Nederlands 2016-03-04  
Portrazza : EPAR - Summary for the public PL = polski 2016-03-04  
Portrazza : EPAR - Summary for the public PT = português 2016-03-04  
Portrazza : EPAR - Summary for the public RO = română 2016-03-04  
Portrazza : EPAR - Summary for the public SK = slovenčina 2016-03-04  
Portrazza : EPAR - Summary for the public SL = slovenščina 2016-03-04  
Portrazza : EPAR - Summary for the public FI = suomi 2016-03-04  
Portrazza : EPAR - Summary for the public SV = svenska 2016-03-04  
Portrazza : EPAR - Summary for the public HR = Hrvatski 2016-03-04  
Name Language First published Last updated
Portrazza : EPAR - Risk-management-plan summary (English only) 2016-03-04  

This EPAR was last updated on 05/12/2016 .

Authorisation details

Product details

Product details for Portrazza
NamePortrazza
Agency product numberEMEA/H/C/003886
Active substance

necitumumab

International non-proprietary name (INN) or common name

necitumumab

Therapeutic area Carcinoma, Non-Small-Cell Lung
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 Portrazza
Marketing-authorisation holder

Eli Lilly Nederland B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union15/02/2016

Contact address:

Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

Product information

10/11/2016  Portrazza -EMEA/H/C/003886 -II/0002

Name Language First published Last updated
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05
Portrazza : EPAR - Product Information EN = English 2016-03-04 2016-12-05

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
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  
Portrazza : EPAR - All Authorised presentations EN = English 2016-03-04  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Portrazza : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-04-13 2016-12-05

Initial marketing-authorisation documents

Name Language First published Last updated
Portrazza : EPAR - Public assessment report EN = English 2016-03-04 2016-09-14
Summary of opinion for Portrazza EN = English 2015-12-18  

Authorised

This medicine is approved for use in the European Union