Revlimid not approved for MDS in EU due to risk for AML

[Birgitta-A]

Hi all,
Revlimid has not been approved for MDS in Europe due to risk for AML transformation. Look at the last of the 51 pages.
http://www.emea.europa.eu/humandocs/...688-WAR-en.pdf
Kind regards
Birgitta-A

[Ruth Cuadra]

Just to be clear, the European study did not implicate Revlimid in causing MDS to transform to AML. There were problems with the study design that did not produce enough comparative data to show sufficient benefit from lenalidomide to warrant the risks. Here is the key passage from the study's conclusions:

Therefore, the data provided were insufficient to demonstrate a favourable benefit/risk balance of lenalidomide in the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a 5q deletion with or without additional cytogenetic abnormalities, or an isolated deletion 5q cytogenetic abnormality...

Regards,
Ruth

[Neil Cuadra]

There is a very readable question-and-answer document from the European Medicines Agency (EMEA):

Questions and Answers on Recommendation for the Refusal of the Marketing Authorisation for Lenalidomide Celgene Europe (PDF, 36K)

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As it explains:

The CHMP had concerns over the way the main study was carried out, which meant that the safety of Lenalidomide Celgene Europe was difficult to assess. In particular, because the study did not compare the medicine to any other treatment, it was difficult to determine if treatment with Lenalidomide Celgene Europe increased the risk of progression to acute myeloid leukaemia.

It also explains that patients in trials and those who petition for "compassionate use" may still have access to the drug:

The company informed the CHMP that it will continue to make lenalidomide available for patients included in clinical trials or compassionate use programmes. If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.