Besponsa

inotuzumab ozogamicin

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

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

What is Besponsa and what is it used for?

Besponsa is a cancer medicine used to treat a type of blood cancer which affects B cells (a type of white blood cells) called B-cell precursor acute lymphoblastic leukaemia (ALL). Besponsa is used on its own in adults whose cancer has come back or did not respond to previous treatment.

Besponsa is only used in patients with ‘CD22-positive B-cell precursor ALL’. This means that patients’ have a particular protein (CD22) on the surface of their white blood cells. In patients who have a type of chromosome known as Philadelphia-chromosome, treatment with a cancer medicine called a tyrosine kinase inhibitor should have been tried before starting Besponsa.

Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare’, and Besponsa was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 7 June 2013.

Besponsa contains the active substance inotuzumab ozogamicin.

How is Besponsa used?

Besponsa is given as an infusion (drip) into a vein lasting for at least one hour. The infusions are given on days 1, 8 and 15 of a 3 or 4 week treatment cycle. The doctor may interrupt treatment or reduce the dose, if the patient develops certain serious side effects.

Patients in whom Besponsa works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment. Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment. In patients who do not respond to treatment, Besponsa should be stopped after 3 cycles.

Besponsa can only be obtained with a prescription, and treatment should be given under the supervision of a doctor who has experience in the use of cancer treatments.

For further information, see the package leaflet.

How does Besponsa work?

The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule, N-acetyl-gamma-calicheamicin dimethylhydrazide. The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells. Once attached, the medicine is taken up by the cell where calicheamicin becomes active, causing breaks in the cell’s DNA and thereby killing the cancer cell.

What benefits of Besponsa have been shown in studies?

Besponsa was shown to be more effective than other chemotherapy (medicines to treat cancer) in one main study involving 326 adults with CD22-positive B-cell precursor ALL, which had come back or had not responded to previous treatment. The main measure of effectiveness was response to treatment. Patients were considered to have responded if they had no remaining cancerous B cells in their blood and bone marrow after treatment.

An analysis of the first 218 patients treated showed that after at least 2 cycles of treatment, 81% (88 out of 109) of patients receiving Besponsa responded to treatment compared with 29% (32 out of 109) of patients receiving other chemotherapy. Patients who responded to treatment could proceed to have a stem cell transplant.

What are the risks associated with Besponsa?

The most common side effects with Besponsa (which may affect more than 1 in 5 people) are thrombocytopenia (low blood platelet counts), neutropenia and leucopenia (low white blood cell counts), infection, anaemia (low red blood cell counts), tiredness, haemorrhage (bleeding), fever, nausea (feeling sick), headache, febrile neutropenia (low white cell count with fever), abdominal pain (stomach ache), increased levels of liver enzymes called transaminases and gamma-glutamyltransferase, and hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells).

The most serious side effects are infection, febrile neutropenia, haemorrhage, abdominal pain, fever, tiredness and veno-occlusive liver disease/sinusoidal obstruction syndrome (VOD/SOS, a serious liver disease).

Besponsa must not be used in patients who have VOD/SOS or have had severe VOD/SOS or have other serious liver diseases.

For the full list of all side effects and restrictions reported with Besponsa, see the package leaflet.

Why is Besponsa approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Besponsa’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP considered that although there have been recent advances in the treatment of B-cell precursor ALL, treatment options for patients remain limited. The main study showed that Besponsa was better than other commonly used chemotherapy medicines at inducing a response in patients and allowing them to have a curative stem cell transplant.

With regard to safety, the side effects with Besponsa are similar to those of other chemotherapy medicines and can usually be managed by dose reduction or treatment interruption.

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

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

Other information about Besponsa

The European Commission granted a marketing authorisation valid throughout the European Union for Besponsa on 29 June 2017.

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

Name Language First published Last updated
Besponsa : EPAR - Summary for the public BG = bălgarski 2017-07-13  
Besponsa : EPAR - Summary for the public ES = español 2017-07-13  
Besponsa : EPAR - Summary for the public CS = čeština 2017-07-13  
Besponsa : EPAR - Summary for the public DA = dansk 2017-07-13  
Besponsa : EPAR - Summary for the public DE = Deutsch 2017-07-13  
Besponsa : EPAR - Summary for the public ET = eesti keel 2017-07-13  
Besponsa : EPAR - Summary for the public EL = elliniká 2017-07-13  
Besponsa : EPAR - Summary for the public EN = English 2017-07-13  
Besponsa : EPAR - Summary for the public FR = français 2017-07-13  
Besponsa : EPAR - Summary for the public IT = italiano 2017-07-13  
Besponsa : EPAR - Summary for the public LV = latviešu valoda 2017-07-13  
Besponsa : EPAR - Summary for the public LT = lietuvių kalba 2017-07-13  
Besponsa : EPAR - Summary for the public HU = magyar 2017-07-13  
Besponsa : EPAR - Summary for the public MT = Malti 2017-07-13  
Besponsa : EPAR - Summary for the public NL = Nederlands 2017-07-13  
Besponsa : EPAR - Summary for the public PL = polski 2017-07-13  
Besponsa : EPAR - Summary for the public PT = português 2017-07-13  
Besponsa : EPAR - Summary for the public RO = română 2017-07-13  
Besponsa : EPAR - Summary for the public SK = slovenčina 2017-07-13  
Besponsa : EPAR - Summary for the public SL = slovenščina 2017-07-13  
Besponsa : EPAR - Summary for the public FI = suomi 2017-07-13  
Besponsa : EPAR - Summary for the public SV = svenska 2017-07-13  
Besponsa : EPAR - Summary for the public HR = Hrvatski 2017-07-13  

This EPAR was last updated on 13/07/2017 .

Authorisation details

Product details

Product details for Besponsa
NameBesponsa
Agency product numberEMEA/H/C/004119
Active substance

inotuzumab ozogamicin

International non-proprietary name (INN) or common name

inotuzumab ozogamicin

Therapeutic area Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code L01XC
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.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Besponsa
Marketing-authorisation holder

Pfizer Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union29/06/2017

Contact address:

Pfizer Limited
821 Ramsgate Road 
Sandwich 
Kent 
CT13 9NJ 
United Kingdom

Product information

Product information

29/06/2017  Besponsa -EMEA/H/C/004119 --

Name Language First published Last updated
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  
Besponsa : EPAR - Product Information HR = Hrvatski 2017-07-13  

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
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  
Besponsa : EPAR - All Authorised presentations HR = Hrvatski 2017-07-13  

Pharmacotherapeutic group

Antineoplastic Agents

Therapeutic indication

Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Besponsa : EPAR - Public assessment report HR = Hrvatski 2017-07-13  
CHMP summary of positive opinion for Besponsa HR = Hrvatski 2017-04-21  

Authorised

This medicine is approved for use in the European Union

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