European Medicines Agency Recommends a New Indication for Lenalidomide

On 18 December 2014, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product lenalidomide (Revlimid). The marketing authorisation holder for this medicinal product is Celgene Europe Limited. They may request a re-examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The CHMP adopted a new indication as follows:

• Lenalidomide is indicated for the continuous treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
• Detailed conditions for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

For information, the full indications for lenalidomide will be as follows:

• Lenalidomide is indicated for the continuous treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
• Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
• Lenalidomide is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.