Anglo-American drugmaker Bioenvision said on Friday its Evoltra product has been recommended for approval in the European Union as a treatment for acute lymphoblastic leukaemia, the most prevalent form of cancer among children.

Evoltra (clofarabine) should be approved by the European Medicines Agency for paediatric ALL patients who have relapsed or are refractory to at least two prior regimens, according to the EMEA’s Committee for Medicinal Products for Human Use (CHMP).

It is the first drug developed specifically for ALL in children to reach this regulatory stage in the EU, said Bioenvision in a statement.

Bioenvision has rights outside the USA and Canada to Evoltra, which was originally developed by the US firm ILEX Oncology, and acquired by Genzyme at the end of 2004. Genzyme markets clofarabine for paediatric leukaemia as Clolar in the USA.

Evoltra is not expected to be a big-selling product, as the majority of paediatric ALL patients respond well to first-line therapy, but it will likely be an invaluable new option for the minority who do fail treatment. Approximately 20% of children with ALL do not achieve long-term survival.

Genzyme does not break down sales of Clolar in its results statements, but said last month that overall revenues from oncology - including Clolar revenues, royalties on licensed products and R&D milestones - was $47 million for the year.

Meanwhile, Bioenvision is developing clofarabine for other cancer indications, including haematological malignancies that mainly affect adults (acute myelogenous leukaemia and chronic lympocytic leukaemia), as well as various solid tumours.