Celgene’s Vidaza receives CHMP backing for elderly patients

Celgene has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended its drug Vidaza for an expanded indication.

The drug has been endorsed for EU approval as a treatment for adult patients aged 65 years or older with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplantation.

If approved, the expanded indication would covers patients who have more than 30 percent myeloblasts, according to the World Health Organization classification; previously, the indication covered AML patients with blasts of 30 percent or less.

The CHMP decision was based on data from AML-001, a pivotal study of patients at least 65 years old with newly-diagnosed or secondary AML with 30 percent or more bone marrow blasts.

Tuomo Patsi, president of Celgene in Europe, the Middle East and Africa, said: "With the positive CHMP opinion for Vidaza in AML, Celgene has an opportunity to advance the treatment options available to patients with AML."

Last month, the company completed its acquisition of Receptos, a deal that will considerably strengthen its inflammation and immunology presence.