European regulators have expanded the reach of Celgene’s acute myeloid leukaemia treatment Vidaza so that elderly patients unable to undergo intensive therapies such as stem cell transplantation can now access the drug.
The European Commission has approved Vidaza (azacitidine) to treat AML patients aged 65 years or older who are not eligible for haematopoietic stem cell transplantation (HSCT), a group likely to die within months of diagnosis and for whom survival rates haven’t improved in more than 40 years.
Also, Vidaza’s labelling has been updated to include AML patients who have >30% myeloblasts (white blood cell in the bone marrow); previously only those with <30% blasts were covered, Celgene said.
The EC’s decision came on the back of clinical data showing that median overall survival was 10.4 months for patients receiving the drug versus 6.5 months for those taking conventional treatment regimens, bringing new hope to those unable take the HSCT route.
More than 14,000 people suffer from AML in Europe, and most will die less than a year after being diagnosed.