The European Commission (EC) has approved Celgene’s Revlimid (lenalidomide) to treat patients with a rare form of the blood cancer myelodysplastic syndrome (MDS).
Specifically, the recommendation covers the use of Revlimid in patients with MDS who have transfusion-dependent anaemia and whose condition is associated with a genetic abnormality known as isolated deletion 5q.
Patients must also have tried other therapeutic options that have proven to be insufficient or inadequate.
The approval adds to Revlimid’s current EU recommendation for use in combination with dexamethasone to treat adults with multiple myeloma.
In the US, the drug is marketed for both multiple myeloma and the MDS indication, and this month it added a mantle cell lymphoma indication to its list of approved uses.
Revlimid’s latest EU approval means patients with MDS – a type of cancer that disrupts the production of blood cells and platelets – have an alternative to red blood cell transfusion, which can be a “tremendous burden” to patients, according to Professor Ghulam Mufti, professor of haematological oncology at King’s College London.
This is especially significant as many people with the disease are elderly.
It is thought that MDS affects 2,000 people each year in the UK, half of which will have some form of genetic abnormality.
Of this group, about one third will have the specific 5q abnormality that Revlimid is approved for.
The drug has demonstrated its efficacy in this indication in clinical trials, with 55 per cent of patients on Revlimid achieving the primary endpoint of transfusion independence compared to just 6.0 per cent of patients in the placebo arm.
“Celgene has pursued an indication for this rare disease for nearly seven years, and after much perseverance, we are proud to now be able to start the important work of partnering with our many stakeholders to ensure patients have access to lenalidomide for MDS isolated del 5q,” said Alan Colowick, president of Celgene EMEA.
