Drug

IBRANCE®

palbociclib

Ibrance Overview

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.

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.

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.

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.

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.

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.

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.

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.

Ibrance must not be used by patients who are taking St John’s wort (a herbal preparation used to treat depression). 

Owner of copyright and other intellectual property rights to European Medicines Agency

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