Oral fludarabine
Oral fludarabine is a nucleoside analogue that prevents cancer cells from dividing by inhibiting DNA synthesis. Oral fludarabine is approved in over 50 countries but not currently in the US. Oral fludarabine has been granted Orphan Drug status by the FDA for use in the treatment of chronic lymphocytic leukaemia (CLL). A New Drug Application (NDA) is currently under review at the FDA for marketing approval for the second-line treatment of CLL.
Publications
Activity of Oral Fludarabine Phosphate in
Previously Treated Chronic Lymphocytic
Leukemia
Boogaerts, M., Van Hoof, A., Catovsky, D., Kovacs, M., Montillo,
M., Zinzani, P., Binet, J., Feremans, W., Marcus, R., Bosch, F.,
Verhoef, G., and Klein, M.
Journal of Clinical Oncology, Vol 19, No 22 (November 15), 2001: pp
4252-4258
Efficacy and Safety of Oral Fludarabine
Phosphate in Previously Untreated Patients with Chronic
Lymphocytic Leukemia
Rossi, J., Van Hoof, A.,
De Boeck, K., Johnson, S., Bron, D., Foussard, C., Lister, T.,
Berthou, C., Kramer, M., Littlewood, T., Marcus, R., Deconinck,
E., Montillo, M., Guibon, O., and Tollerfield, S.
Journal of Clinical Oncology, Vol 22, No 7 (April 1), 2004: pp
1260-1267
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