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The UK National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Celgene‘s Revlimid (lenalidomide) to treat myelodysplastic syndromes (MDS).

MDS are a group of bone marrow disorders, which are characterised by the underproduction of one or more types of blood cells due to dysfunction of the marrow.

In the draft guidance, NICE recommends the use of lenalidomide to treat people with a specific type of MDS that is characterised by a chromosomal abnormality, called an isolated deletion 5q cytogenetic abnormality.

NICE chief executive Sir Andrew Dillon said: "The committee heard from clinical experts that lenalidomide is an effective therapy. Celgene – who market lenalidomide – worked with us to provide enough evidence to make it possible for us to recommend it for this group of people.

"The committee heard from clinical experts that lenalidomide is an effective therapy."

"Celgene provided a revised analyses and further information on their proposal for a reduction in the cost of the drug to the NHS (patient access scheme)."

The guidance was based on the results of MDS-004, the largest global trial of MDS del(5q) patients conducted to date, according to Celgene.

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Lenalidomide has marketing authorisation to treat transfusion-dependent anaemia, caused by low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality, when other therapeutic options are insufficient or inadequate.

NICE added that lenalidomide is available in 21-day packs of 10mg and 5mg capsules, at net prices of £3780 and £3570 respectively.


Image: Therapy-related myelodysplastic syndrome. Photo: courtesy of the Armed Forces Institute of Pathology (AFIP).