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Lenalidomide authorisation refusal recommended


The Committee for Medicinal Products for Human Use (CHMP) of the EMEA has adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product lenalidomide, intended for treating anaemia due to myelodysplastic syndromes (MDS).

Lenalidomide, under the brand name Revlimid®, is currently approved in the UK for treating multiple myeloma.

Lenalidomide Celgene Europe was expected to be used to treat anaemia caused by MDS (associated with deletion of part of chromosome number 5), in patients dependent on blood transfusions and who had a low to intermediate risk of progressing to leukaemia or death.

According to the Question and Answers document, the CHMP was of the opinion that the benefits of Lenalidomide Celgene Europe in the treatment of this condition did not outweigh its potential risks.

There were some concerns expressed over the main study, including its design and the recording of results.

EMEA Q&A document

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