Ibrance

palbociclib

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

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

What is Ibrance and what is it used for?

Ibrance is a cancer medicine used to treat locally advanced or metastatic breast cancer (cancer that has begun to spread to other parts of the body). Ibrance can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not produce abnormally large quantities of a receptor called HER2 (HER [human epidermal growth factor] negative). Ibrance is used in the following ways:

  • together with an aromatase inhibitor (a hormonal medicine for cancer);
  • together with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.
    In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.

Ibrance contains the active substance palbociclib.

How is Ibrance used?

Ibrance can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.

Ibrance is available as capsules (75 mg, 100 mg and 125 mg). The recommended dose is 125 mg once a day for 21 consecutive days, followed by a 7-day break to complete a 28-day treatment cycle. The capsules should be given with food at around the same time each day. Treatment should continue for as long as the patient is benefitting from it and side effects are tolerable. If the patient experiences certain side effects, treatment may need to be interrupted or stopped, or the dose reduced.

For further information, see the package leaflet.

How does Ibrance work?

The active substance in Ibrance, palbociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide. In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably. By blocking CDK4 and CDK6, Ibrance slows the growth of HR-positive breast cancer cells.

What benefits of Ibrance have been shown in studies?

Ibrance has been studied in two main studies of women with HR-positive, HER2-negative breast cancer. In both studies, the main measure of effectiveness was how long patients lived without their disease getting worse (progression-free survival).

The first study involved 521 women with metastatic breast cancer that had got worse after treatment with a hormonal medicine. They received either Ibrance and fulvestrant or a placebo (dummy medicine) and fulvestrant. Women taking Ibrance and fulvestrant lived on average 11.2 months without their disease getting worse compared with 4.6 months for women taking placebo and fulvestrant.

The second study involved 666 women who had been through the menopause and whose breast cancer had started to spread and who had not yet received cancer treatment. They received either Ibrance and letrozole (an aromatase inhibitor) or placebo and letrozole. Women taking Ibrance and letrozole lived on average 24.8 months without their disease getting worse compared with 14.5 months for women taking placebo and letrozole.

What are the risks associated with Ibrance?

The most common side effects with Ibrance (which may affect more than 1 in 5 people) are neutropenia (low blood levels of neutrophils, a type of white blood cell that fights infection), infections, leucopenia (low white blood cell counts), tiredness, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), anaemia (low red blood cell counts), alopecia (hair loss) and diarrhoea.

The most common severe side effects with Ibrance (which may affect up to 1 in 50 people) are neutropenia, leucopenia, anaemia, tiredness and infections.

For the full list of all side effects reported with Ibrance, see the package leaflet.

Ibrance must not be used by patients who are taking St John’s wort (a herbal preparation used to treat depression). For the full list of restrictions, see the package leaflet.

Why is Ibrance approved?

Ibrance has been shown to prolong the time patients live without their disease getting worse by an average of 6 to 10 months, which is considered of clear clinical value. Regarding safety, the main risk is neutropenia, which is a well-known risk of many cancer medicines and is considered manageable.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Ibrance’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 Ibrance?

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

Other information about Ibrance

The European Commission granted a marketing authorisation valid throughout the European Union for Ibrance on 9 November 2016.

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

Name Language First published Last updated
Ibrance : EPAR - Summary for the public BG = bălgarski 2016-11-25  
Ibrance : EPAR - Summary for the public ES = español 2016-11-25  
Ibrance : EPAR - Summary for the public CS = čeština 2016-11-25  
Ibrance : EPAR - Summary for the public DA = dansk 2016-11-25  
Ibrance : EPAR - Summary for the public DE = Deutsch 2016-11-25  
Ibrance : EPAR - Summary for the public ET = eesti keel 2016-11-25  
Ibrance : EPAR - Summary for the public EL = elliniká 2016-11-25  
Ibrance : EPAR - Summary for the public EN = English 2016-11-25  
Ibrance : EPAR - Summary for the public FR = français 2016-11-25  
Ibrance : EPAR - Summary for the public IT = italiano 2016-11-25  
Ibrance : EPAR - Summary for the public LV = latviešu valoda 2016-11-25  
Ibrance : EPAR - Summary for the public LT = lietuvių kalba 2016-11-25  
Ibrance : EPAR - Summary for the public HU = magyar 2016-11-25  
Ibrance : EPAR - Summary for the public MT = Malti 2016-11-25  
Ibrance : EPAR - Summary for the public NL = Nederlands 2016-11-25  
Ibrance : EPAR - Summary for the public PL = polski 2016-11-25  
Ibrance : EPAR - Summary for the public PT = português 2016-11-25  
Ibrance : EPAR - Summary for the public RO = română 2016-11-25  
Ibrance : EPAR - Summary for the public SK = slovenčina 2016-11-25  
Ibrance : EPAR - Summary for the public SL = slovenščina 2016-11-25  
Ibrance : EPAR - Summary for the public FI = suomi 2016-11-25  
Ibrance : EPAR - Summary for the public SV = svenska 2016-11-25  
Ibrance : EPAR - Summary for the public HR = Hrvatski 2016-11-25  

This EPAR was last updated on 17/01/2017 .

Authorisation details

Product details

Product details for Ibrance
NameIbrance
Agency product numberEMEA/H/C/003853
Active substance

palbociclib

International non-proprietary name (INN) or common name

palbociclib

Therapeutic area Breast Neoplasms
Anatomical therapeutic chemical (ATC) code L01XE33
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 Ibrance
Marketing-authorisation holder

Pfizer Limited

Revision1
Date of issue of marketing authorisation valid throughout the European Union09/11/2016

Contact address:

Pfizer Limited
Ramsgate Road 
Sandwich 
Kent CT13 9NJ 
United Kingdom

Product information

Product information

28/11/2016  Ibrance -EMEA/H/C/003853 -N/0001

Name Language First published Last updated
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17
Ibrance : EPAR - Product Information HR = Hrvatski 2016-11-25 2017-01-17

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
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  
Ibrance : EPAR - All Authorised presentations HR = Hrvatski 2016-11-25  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:

  • in combination with an aromatase inhibitor;
  • in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1).

In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ibrance : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-01-17  

Initial marketing-authorisation documents

Name Language First published Last updated
Ibrance : EPAR - Public assessment report HR = Hrvatski 2016-11-25  
CHMP summary of positive opinion for Ibrance HR = Hrvatski 2016-09-16