Pixuvri

pixantrone dimaleate

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This is a summary of the European public assessment report (EPAR) for Pixuvri. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pixuvri.

What is Pixuvri?

Pixuvri is a medicine that contains the active substance pixantrone. It is available as a powder that is made up into a solution for infusion (a drip into a vein).

What is Pixuvri used for?

Pixuvri is used to treat adult patients with non-Hodgkin’s B-cell lymphoma. This is a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells. Pixuvri is used when the lymphoma is aggressive and has come back or has not responded to other chemotherapy treatments (medicines to treat cancer).

The medicine can only be obtained with a prescription.

How is Pixuvri used?

Pixuvri must be given by a doctor who has experience in the use of anticancer medicines and who has access to facilities for monitoring the patient.

The dose of Pixuvri is based on the patient’s body surface area (calculated using the patient’s height and weight). The recommended dose is 50 mg/m2 given as an infusion into a vein over at least 60 minutes on days 1, 8 and 15 of a 28-day cycle. Pixuvri can be given for up to six cycles. In patients who develop side effects or who have very low blood levels of neutrophils (a type of white blood cell that fights infection) and platelets (components that help the blood to clot), the dose may have to be reduced or treatment may have to be delayed.

How does Pixuvri work?

The active substance in Pixuvri, pixantrone, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anthracyclines’. It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins. This means that the cancer cells in non-Hodgkin’s B-cell lymphoma cannot divide and eventually die.

How has Pixuvri been studied?

The effects of Pixuvri were first tested in experimental models before being studied in humans.

Pixuvri was compared with other chemotherapy treatments in one main study involving 140 adults with aggressive non-Hodgkin’s B-cell lymphoma, who had previously received at least two other treatments, and whose cancer had come back or had not responded to treatment. Patients were given either six cycles of Pixuvri or another approved anticancer medicine chosen by their doctor.

The main measure of effectiveness was the number patients who had a complete response to treatment.

What benefit has Pixuvri shown during the studies?

Pixuvri was shown to be beneficial in patients with aggressive non-Hodgkin’s B-cell lymphoma: 20% of patients responded completely to Pixuvri (14 out of 70 patients) compared with 5.7% of patients receiving other agents (4 out of 70 patients).

What is the risk associated with Pixuvri?

The most common side effects with Pixuvri (seen in more than 1 patient in 10) are neutropenia, leucopenia and lymphopenia (low levels of different types of white blood cells), thrombocytopenia (low levels of platelets in the blood), anaemia (low levels of red blood cells), nausea (feeling sick), vomiting, skin discolouration, hair loss, chromaturia (abnormal colouration of the urine) and asthenia (weakness). For the full list of all side effects reported with Pixuvri, see the package leaflet.

Pixuvri must not be used in patients who are hypersensitive (allergic) to pixantrone or any of the other ingredients. It must not be used in patients with severe liver problems and in patients whose bone marrow produces abnormally low levels of blood cells. Patients receiving Pixuvri must not be given vaccines containing attenuated (weakened live) viruses.

Why has Pixuvri been approved?

The CHMP concluded that patients with aggressive non-Hodgkin’s B-cell lymphoma had a better response to treatment with Pixuvri than other cancer treatments. In addition, patients treated with Pixuvri lived for longer without their disease getting worse. The CHMP also considered the seriousness of the disease and the lack of suitable alternative treatments for patients whose non-Hodgkin’s B-cell lymphoma has come back or has not responded to other chemotherapy treatments. The side effects of the medicine were considered to be short term and manageable. However, the Committee noted that more data were needed on the benefits of Pixuvri in patients who have received previous treatment with rituximab (another medicine commonly used to treat lymphoma). The CHMP concluded that the benefits of Pixuvri are greater than its risks and recommended that it be given marketing authorisation.

Pixuvri has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular its benefits in patients who have previously been treated with rituximab. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Pixuvri?

The company that makes Pixuvri will carry out a study to further investigate the effects of using Pixuvri in patients who had received prior treatment with rituximab.

Other information about Pixuvri

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Pixuvri on 10 May 2012.

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

Name Language First published Last updated
Pixuvri : EPAR - Summary for the public BG = bălgarski 31/05/2012  
Pixuvri : EPAR - Summary for the public ES = español 31/05/2012  
Pixuvri : EPAR - Summary for the public CS = čeština 31/05/2012  
Pixuvri : EPAR - Summary for the public DA = dansk 31/05/2012  
Pixuvri : EPAR - Summary for the public DE = Deutsch 31/05/2012  
Pixuvri : EPAR - Summary for the public ET = eesti keel 31/05/2012  
Pixuvri : EPAR - Summary for the public EL = elliniká 31/05/2012  
Pixuvri : EPAR - Summary for the public EN = English 31/05/2012  
Pixuvri : EPAR - Summary for the public FR = français 31/05/2012  
Pixuvri : EPAR - Summary for the public IT = italiano 31/05/2012  
Pixuvri : EPAR - Summary for the public LV = latviešu valoda 31/05/2012  
Pixuvri : EPAR - Summary for the public LT = lietuvių kalba 31/05/2012  
Pixuvri : EPAR - Summary for the public HU = magyar 31/05/2012  
Pixuvri : EPAR - Summary for the public MT = Malti 31/05/2012  
Pixuvri : EPAR - Summary for the public NL = Nederlands 31/05/2012  
Pixuvri : EPAR - Summary for the public PL = polski 31/05/2012  
Pixuvri : EPAR - Summary for the public PT = português 31/05/2012  
Pixuvri : EPAR - Summary for the public RO = română 31/05/2012  
Pixuvri : EPAR - Summary for the public SK = slovenčina 31/05/2012  
Pixuvri : EPAR - Summary for the public SL = slovenščina 31/05/2012  
Pixuvri : EPAR - Summary for the public FI = suomi 31/05/2012  
Pixuvri : EPAR - Summary for the public SV = svenska 31/05/2012  

This EPAR was last updated on 06/10/2014 .

Authorisation details

Product details

Product details for Pixuvri
NamePixuvri
Agency product numberEMEA/H/C/002055
Active substance

pixantrone dimaleate

International non-proprietary name (INN) or common name

pixantrone dimaleate

Therapeutic area Lymphoma, Non-Hodgkin
Anatomical therapeutic chemical (ATC) code L01DB11
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 Pixuvri
Marketing-authorisation holder

CTI Life Sciences Limited

Revision9
Date of issue of marketing authorisation valid throughout the European Union10/05/2012

Contact address:

CTI Life Sciences Limited
Highlands House
Basingstoke Road
Spencers Wood, Reading
Berkshire RG7 1NT
United Kingdom

Product information

Product information

01/09/2014  Pixuvri -EMEA/H/C/002055 -PSUV/0015

Name Language First published Last updated
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014
Pixuvri : EPAR - Product Information SV = svenska 31/05/2012 06/10/2014

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
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  
Pixuvri : EPAR - All Authorised presentations SV = svenska 31/05/2012  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Pixuvri : EPAR - Public assessment report SV = svenska 31/05/2012  
CHMP summary of positive opinion for Pixuvri SV = svenska 17/02/2012  

Authorised

This medicine is approved for use in the European Union

More information on Pixuvri