Overview

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

Vidaza is a medicine that contains the active substance azacitidine. It is available as a powder to be made up into a suspension for injection.

Vidaza is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow’s ability to produce healthy blood cells):

  • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Vidaza is used in patients with an intermediate to high risk of progressing to AML or death;
  • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes). Vidaza is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
  • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
  • AML, when the bone marrow has more than 30% abnormal cells.

Because the number of patients with these diseases is low, the diseases are considered ‘rare’, and Vidaza was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 6 February 2002 for myelodysplastic syndromes and on 29 November 2007 for AML. At the time of orphan medicine designation, CMML was classified as a type of myelodysplastic syndrome.

The medicine can only be obtained with a prescription.

Vidaza treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines. Patients should receive medicines to prevent nausea (feeling sick) and vomiting before giving Vidaza.

The recommended dose of Vidaza is 75 mg per square metre body surface area (calculated using the patient’s height and weight). It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for one week, followed by three weeks with no treatment. This four-week period is one ‘cycle’. Treatment continues for at least six cycles and then for as long as it benefits the patient. The liver, kidneys and blood should be checked before each cycle. If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.

See the summary of product characteristics (also part of the EPAR) for full details.

The active substance in Vidaza, azacitidine, belongs to the group ‘anti?metabolites’. Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA). It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA. These actions are thought to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.

Vidaza has been studied in two main studies. The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML, who were unlikely to go on to have a stem cell transplant. The patients’ bone marrow contained up to 30% abnormal cells. The second study involved 488 patients with AML who were 65 years or older and could not have haematopoietic stem cell transplantation. Their bone marrow contained more than 30% abnormal cells. Both studies compared Vidaza with conventional care (treatment chosen for each patient based on local practice and the patient’s condition). The main measure of effectiveness was how long the patients survived.

Vidaza was more effective than conventional care in extending survival. In the first study, patients receiving Vidaza survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care. The effect of Vidaza was similar in all three diseases.

In the second study in AML patients with more than 30% abnormal cells, patients receiving Vidaza survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.

The most common side effects of Vidaza in more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells) are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions. Side effects were similar in AML patients with more than 30% abnormal cells. For the full list of all side effects reported with Vidaza, see the package leaflet.

Vidaza must not be used in patients with advanced liver cancer or in women who are breastfeeding. For the full list of restrictions, see the package leaflet.

The CHMP decided that Vidaza’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vidaza 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 Vidaza on 17 December 2008.

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

Vidaza : EPAR - Summary for the public

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Vidaza : EPAR - Risk-management-plan

Product information

Vidaza : EPAR - Product Information

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Latest procedure affecting product information: IAIN/0059

06/12/2023

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This medicine’s product information is available in all official EU languages.
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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Vidaza : EPAR - All Authorised presentations

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Product details

Name of medicine
Vidaza
Active substance
azacitidine
International non-proprietary name (INN) or common name
azacitidine
Therapeutic area (MeSH)
  • Myelodysplastic Syndromes
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myeloid, Acute
Anatomical therapeutic chemical (ATC) code
L01BC07

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: 

  • intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
  • chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder,
  • acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification.

Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.

Authorisation details

EMA product number
EMEA/H/C/000978

Accelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Opinion adopted
23/10/2008
Marketing authorisation issued
17/12/2008
Revision
27

Assessment history

Vidaza : EPAR - Procedural steps taken and scientific information after authorisation

Vidaza-H-C-PSUSA-00000274-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Vidaza-H-C-978-P46-035 : EPAR - Assessment report

Vidaza-H-C-978-P46-034.1 : EPAR - Assessment Report

Vidaza-H-C-PSUSA-00000274-201805 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Vidaza : EPAR - Scientific Conclusion

Vidaza-H-C-978-II-0030 : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Vidaza-II-30

Vidaza-H-C-978-PSUV-0029 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Vidaza-H-C-978-A20-0017: EPAR - Assessment Report - Article 20

Vidaza : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Vidaza

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