Janssen receives European approval for leukaemia drug Dacogen

Janssen has been granted approval from the European Commission to launch Dacogen, its new acute myeloid leukaemia (AML) therapy.

The drug has received marketing authorisation for the treatment of patients aged 65 years and above with newly diagnosed de novo or secondary AML who have been deemed unsuitable for standard induction chemotherapy.

Data from the phase III Daco-016 study – the largest AML trial to date for older patients – showed that the drug is able to deliver improvements in median overall survival rates.

The product is also currently approved for the treatment of myelodysplastic syndromes in more than 35 countries worldwide.

Dr Peter Lebowitz, oncology therapeutic area head for Janssen research and development, said: "Dacogen nicely complements our growing portfolio of therapies to treat haematologic malignancies, which is one of our key areas of focus in oncology."

Last month, the company applied for European regulatory approval of the investigational compound bedaquiline for the treatment of pulmonary multi-drug resistant tuberculosis.