Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation announced that the European Commission (EC) has approved Vidaza (azacitidine for injection) for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplantation (HSCT).
The Vidaza marketing authorisation has been updated to include this new indication in AML, covering patients who have > 30 per cent myeloblasts according to the WHO classification; previously, the indication covered AML patients with < 30 per cent blasts.
Today’s approval marks the fourth new product or extension of the indication approved by the EC in the EU for Celgene in 2015. Celgene received approvals in the first quarter of the year for Revlimid in newly diagnosed multiple myeloma in adult patients ineligible for transplantation; Otezla, the first phosphodiesterase-4 (PDE-4) inhibitor in psoriasis and psoriatic arthritis; and Abraxane in non-small cell lung cancer.
In the United States, Vidaza is not indicated for treatment of patients with AML. Vidaza is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anaemia (RA) or refractory anaemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).