EU drug approval for MDS sub-type del 5q28 Apr. 2013
Great and long awaited positive news:
Lenalidomide/Revlimid – the drug developed by pharma company Celgene has finally received approval for use in Europe – for transfusion dependent MDS patients who have the sub-type del 5q (also called 5q-).
This is wonderful news, as approval has been long awaited by MDS 5q- patients all over Europe.
The drug had been approved by the FDA in the USA – and in use there for several years – but the European Medicines Agency had insisted on further trials and data before approving its use for Europe.
The EMA looks specifically at the safety aspect of new drugs.
Some UK (and European) 5q- MDS patients had been receiving treatment with lenalidomide already – but only on a trial basis.
For the UK specifically, this drug will now go through the NICE assessment system to determine its cost-effectiveness.
We will post further news about this soon – as patients are encouraged to send comments to NICE.
The NICE meeting will take place in June.
For the time being, lenalidomide/Revlimid will be available to MDS patients in the UK via the Cancer Drug Fund.
Here are the full details regarding the EMA decision:
Link to full PDF document and details EMA decision on Revlimid/Lenalidomide
On 25 April 2013, the 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 Revlimid. The marketing authorisation holder for this medicinal product is Celgene Europe Limited.
The CHMP adopted a new indication as follows:
“Myelodysplastic syndromes Revlimid is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.”
For further information about EMA: EMA website