Oral Fludara launched in first market

Schering AG of Germany has launched a new oral formulation of its cancertreatment fludarabine in the UK, its first market, for the second-line treatment of patients with B cell chronic lymphocytic leukemia. Fludara Oral is expected to be useful in patients who find it difficult to visit hospitals for treatment with the intravenous form.

Sales of the original formulation of Fludara reached 82 million euros ($72.9 million) in the first nine months of 2000, a healthy rise of 36% over the same period of 1999. CLL is the most common form of leukemia in adults in the west, and remains an incurable disease. Intravenous fludarabine has emerged as the gold-standard second-line therapy, after alkylating agents, for B cell CLL patients.

The UK is acting as the rapporteur for the oral version for other European Union country approvals under the mutual recognition procedure. Meanwhile, Schering's CLL franchise may soon be extended further, following the backing of its Campath (alemtuzumab) by a US Food and Drug Administration advisory panel towards the end of last year. Campath is intended for use in patients who have failed alkylating agents and fludarabine. A dossier for the drug in CLL is also under review at the European Medicines Evaluation Agency.