Schering Launches Fludara In UK

Schering Health Care has launched Fludara (fludarabine phosphate), a purine analog, in the UK for the second-line treatment of B-cell chronic lymphocytic leukemia in those patients who are unresponsive to, or who have relapsed after, a standard treatment regimen including alkylating agents.

In clinical trials involving several hundred pretreated patients with CLL, fludarabine achieved an overall response rate of up to 58%. One trial comparing fludarabine in 103 pretreated patients with the CAP regimen (cyclophosphamide, doxorubicin and prednisolone), showed a significantly greater response in the fludarabine arm (45.3% vs 26%). After administration, fludarabine is dephosphorylated before being taken up selectively by lymphoid cells. Once in the cells, it is converted to the active triphosphate form. The triphosphate inhibits the enzymes involved in DNA synthesis, repair and replication. Partial RNA inhibition also occurs.

Work is currently being undertaken to investigate the potential of combining fludarabine with cytosine arabinoside and cisplatin, which appear to offer synergistic activity in CLL patients. An oral formulation of the drug is also under development, and may be suitable for first-line therapy of the condition.