EC approves Celgene’s Vidaza as new treatment for acute myeloid leukaemia

Vidaza is indicated to treat adult patients aged 65 years or older with AML who are not eligible for haematopoietic stem cell transplantation (HSCT).

The commission updated Vidaza marketing authorisation to include the new indication in AML, covering patients who have more than 30% myeloblasts according to the WHO classification.

The earlier indication covered AML patients with less than 30% myeloblasts, which are white cells in the bone marrow.

Celgene carried out a global, multi-centre, randomized, open-label pivotal study of patients at least 65 years old with newly diagnosed or secondary AML with greater than 30% bone marrow blasts.

The company compared Vidaza plus best supportive care (n=241) with conventional care regimens (n=247).

Median overall survival, the primary endpoint of the study, was 10.4 months for patients receiving azacitidine compared with 6.5 months for people receiving conventional treatment regimens.

The approval for Vidaza is the fourth new product or extension of the indication secured by Celgene in this year from the EC in the European Union.

In the first quarter, the company secured approvals for Revlimid in newly diagnosed multiple myeloma in adult patients ineligible for transplantation; Otezla, the first phosphodiesterase-4 inhibitor in psoriasis and psoriatic arthritis; and Abraxane in non-small cell lung cancer.