Bosulif

bosutinib

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About

An overview of Bosulif and why it is authorised in the EU

Bosulif is a cancer medicine that is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in adults with a special chromosome in their cells called the Philadelphia chromosome.

It is used to treat three stages of CML called ‘chronic phase’, ‘accelerated phase’ and ‘blast phase’ in patients who have already been treated with one or more tyrosine kinase inhibitors (medicines for CML which work in a similar way to Bosulif), and when the tyrosine kinase inhibitors called dasatinib, imatinib and nilotinib are not suitable.

Bosulif is also used to treat newly diagnosed patients who are in the ‘chronic phase’ of CML.

Bosulif contains the active substance bosutinib.

How is Bosulif used?

Bosulif is available as tablets (100, 400 and 500 mg). It can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of CML. The recommended dose is 400 mg once a day for newly diagnosed patients, and 500 mg once a day for patients who have already been treated with other medicines. The doctor may increase the dose up to 600 mg once a day or reduce it or interrupt treatment according to how the medicine is working and the side effects the patient has.

For more information about using Bosulif, see the package leaflet or contact a doctor or pharmacist.

How does Bosulif work?

The active substance in Bosulif, bosutinib, is a tyrosine kinase inhibitor. It blocks the action of enzymes known as Src and Bcr-Abl tyrosine kinases found on leukaemia cells where they are involved in stimulating the cells to divide uncontrollably. By blocking their action, Bosulif helps to control cell division, thereby controlling the growth and spread of the leukaemia cells in CML.

What benefits of Bosulif have been shown in studies?

Studies have shown that Bosulif is effective at reducing the proportion of white blood cells with the Philadelphia chromosome. Bosulif was investigated in one main study involving 570 patients with Ph+ CML who had previously been treated with at least one tyrosine kinase inhibitor. Bosulif was not compared with another treatment. Of these, 52 patients were considered to have an unmet medical need, because disease resistance or the risk of severe side effects made other tyrosine kinase inhibitors unsuitable. Among these patients, 36 had chronic phase CML and 16 had either accelerated or blast phase CML.

The main measure of effectiveness was the number of patients who had at least a ‘major cytogenetic response’ (where the proportion of white blood cells with the Philadelphia chromosome fell below 35%) after six months of Bosulif treatment. Effectiveness was also measured in other ways including ‘haematological response’ (a return to normal of the number of white cells in the blood). Bosulif treatment was effective in patients with an unmet medical need: 18 out of 36 patients with chronic phase CML had a ‘major cytogenetic response’, while 7 out of the 16 patients with advanced (accelerated or blast phase) CML also had a sufficient response based on other measurements.

A second study in 536 newly diagnosed CML patients in the ‘chronic phase’ compared Bosulif with imatinib. The main measure of effectiveness was the number of patients who had a ‘major molecular response’ (where the amount in the bone marrow of BCR-ABL, the protein produced by the Philadelphia chromosome, is greatly lowered). After one year of treatment, 47% (116 out of 246) of patients treated with Bosulif had a major molecular response, compared with 37% (89 out of 241) of patients treated with imatinib.

What are the risks associated with Bosulif?

The most common side effects with Bosulif (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), abdominal pain (belly ache), vomiting, rash, anaemia (low red blood cell counts), tiredness, fever and increased levels of liver enzymes. The most serious side effects (which may affect more than 1 in 20 people) include thrombocytopenia, anaemia, diarrhoea, rash, neutropenia (low levels of neutrophils, a type of white blood cell) and blood tests suggesting damage to the liver and pancreas. For the full list of all side effects reported with Bosulif, see the package leaflet.

Bosulif must not be used in patients with reduced liver function. For the full list of restrictions, see the package leaflet.

Why is Bosulif authorised in the EU?

Bosulif has been shown to improve the condition of patients with CML, including by reducing the number of cancer cells with the Philadelphia chromosome and returning white blood cell levels to normal. The side effects of the medicine are considered to be manageable.

The European Medicines Agency therefore decided that the benefits of Bosulif are greater than in its risks and recommended that it can be authorised for use in the EU.

Bosulif has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Bosulif?

Since Bosulif has been granted a conditional approval, the company that markets Bosulif will carry out and submit the results of a larger study with Bosulif in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom dasatinib, imatinib and nilotinib are not considered appropriate treatment options.

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

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

As for all medicines, data on the use of Bosulif are continuously monitored. Side effects reported with Bosulif are carefully evaluated and any necessary action taken to protect patients.

A risk-management-plan summary is available.

Other information about Bosulif

Bosulif received a marketing authorisation valid throughout the EU on 27 March 2013.

Name Language First published Last updated
Bosulif : EPAR - Medicine overview BG = bălgarski 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview ES = español 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview CS = čeština 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview DA = dansk 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview DE = Deutsch 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview ET = eesti keel 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview EL = elliniká 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview EN = English 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview FR = français 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview IT = italiano 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview LV = latviešu valoda 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview LT = lietuvių kalba 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview HU = magyar 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview MT = Malti 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview NL = Nederlands 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview PL = polski 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview PT = português 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview RO = română 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview SK = slovenčina 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview SL = slovenščina 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview FI = suomi 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview SV = svenska 2013-04-09 2018-05-24
Bosulif : EPAR - Medicine overview HR = Hrvatski 2013-04-09 2018-05-24
Name Language First published Last updated
Bosulif : EPAR - Risk-management-plan summary (English only) 2018-05-07  

This EPAR was last updated on 10/08/2018 .

Authorisation details

Product details

Product details for Bosulif
NameBosulif
Agency product numberEMEA/H/C/002373
Active substance

bosutinib (as monohydrate)

International non-proprietary name (INN) or common name

bosutinib

Therapeutic area Leukemia, Myeloid
Anatomical therapeutic chemical (ATC) code L01XE14
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.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Bosulif
Marketing-authorisation holder

Pfizer Europe MA EEIG

Revision16
Date of issue of marketing authorisation valid throughout the European Union27/03/2013

Contact address:

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles,
Belgium

Product information

Product information

02/08/2018  Bosulif -EMEA/H/C/002373 -T/0032

Name Language First published Last updated
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10
Bosulif : EPAR - Product Information EN = English 2013-04-09 2018-08-10

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
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24
Bosulif : EPAR - All Authorised presentations EN = English 2013-04-09 2016-05-24

Pharmacotherapeutic group

Antineoplastic agents, protein-kinase inhibitors

Therapeutic indication

Bosulif is indicated for the treatment of adult patients with:

  • newly‑diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
  • CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Assessment History

Authorised

This medicine is approved for use in the European Union

More information on Bosulif

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 4 August 2010.

Bosulif was withdrawn from the Community register of orphan medicinal products in March 2018 upon request of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.