Levact - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Levact and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Levact outweigh its risks, and that the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom.

What is Levact?

Levact is an anticancer medicine. It is used to treat the following types of cancer:

• chronic lymphocytic leukaemia (a cancer of a type of white blood cell called lymphocytes) in patients for whom treatment with fludarabine (another anticancer medicine) is not appropriate;
• non-Hodgkin's lymphoma (a cancer of the lymph tissue, part of the immune system) in patients whose cancer got worse during or following treatment containing rituximab (another anticancer medicine);
• multiple myeloma (a cancer of the bone marrow) in combination with prednisone in patients older than 65 years who are not eligible for stem-cell transplantation and cannot be treated with thalidomide or bortezomib (other anticancer medicines).

The active substance in Levact, bendamustine hydrochloride, belongs to a group of anticancer medicines called 'alkylating agents'. It binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide and the growth of tumours slows down.
Bendamustine has been used in anticancer medicines in Germany since the early 1970s.

Why was Levact reviewed?

Astellas Pharma GmbH submitted Levact to the German medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the 'concerned Member States', in this instance Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom).

However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 2 October 2009.

The grounds for the referral were that one Member State, the United Kingdom, could not approve the indication non-Hodgkin's lymphoma, and two Member States, Belgium and France, could not approve the indication multiple myeloma because not enough data on the effectiveness of this medicine were available to support these indications.

What are the conclusions of the CHMP?

The CHMP assessed the two clinical studies presented by the company to support the multiple myeloma and non-Hodgkin's lymphoma indications. Based on the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Levact outweigh its risks for the two indications for which objections were raised. The Committee therefore recommended that Levact be granted marketing authorisation in Germany and all concerned Member States for all the indications that were applied for.

Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion)

AdoptedReference Number: EMEA/H/A-29/1238

Key facts

About this medicine

• Approved name:
  Levact
• International non-proprietary name (INN) or common name:
  bendamustine
• Associated names:
  Ribomustin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1238
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  18/03/2010
• EC decision date:
  07/07/2010

All documents

Levact - Article 29 referral - Annex I, II, III, IV

Adopted

Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion)

AdoptedReference Number: EMEA/H/A-29/1238

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.