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European Commission extends Lenalidomide License

written by

Leukaemia Care, Charity

  • medication

The European Medicines Agency (EMA) has approved an extension to the current licence of lenalidomide, which is marketed by Celgene as Revlimid®.

Lenalidomide has previously been licenced (in combination with dexamethasone) for the treatment of myeloma patients who have received at least one prior therapy (therefore at any stage after first relapse). The outcome of the EMA’s decision is to extend that licence to include newly diagnosed myeloma patients who are ineligible for transplant. The extension of this licence means that lenalidomide can now be marketed throughout the European Union within its approved indication.

However, NHS patients in the UK will be unable to access lenalidomide in its newly extended indication until it has been approved by the relevant health technology appraisal body. The relevant body for England and Wales is the National Institute for Health and Care Excellence (NICE), for Scotland is the Scottish Medicines Consortium (SMC) and for Wales is the All Wales Medicines Strategy Group (AWMSG).

Currently NHS patients in England and Wales can access lenalidomide after two prior therapies (therefore at any stage after two relapses) and NHS patients in Scotland can access it after one prior therapy (at any stage after first relapse).

If you are affected by this change and would like to speak to somebody about it, please call our CARE line on 08088 010 444.