Fludarabine monotherapy for the first-line treatment of chronic lymphocytic leukaemia

2 The technology

2.1 Fludarabine (Fludara, Schering Health Care Limited) is a deoxyadenosine derivative that inhibits DNA, RNA and protein synthesis, and cell replication and growth, leading to apoptosis (cell death). Fludarabine has a marketing authorisation for the first-line treatment of symptomatic B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserves and either advanced disease (Binet stage C, Rai stages III/IV) or Binet stage A/B (Rai stages I/II) with disease-related symptoms or evidence of progressive disease. For further information about the drug, see the SPC.

2.2 The most common adverse events associated with fludarabine treatment include anaemia, thrombocytopenia, neutropenia and infections (for example, pneumonia and herpes virus infections). For full details of side effects and contraindications, see the SPC.

2.3 The unit cost of fludarabine is £156 for a 50-mg vial, and £18.60 per 10-mg tablet, available in packs of 15 and 20 tablets (excluding VAT; 'British national formulary', edition 52). The cost per patient for a course of six cycles of treatment with fludarabine monotherapy would be approximately £4700. Costs may vary in different settings because of negotiated procurement discounts.