News: NICE approves fludarabine; taxane guidance unchanged

The Pharmaceutical Journal Vol 267 No 7167 p415-420
29 September 2001

NICE approves fludarabine; taxane guidance unchanged

Oral fludarabine should be recommended as second line therapy for patients with B-cell chronic lymphocytic leukaemia (CLL), says the National Institute for Clinical Excellence in guidance issued this week.

NICE has also issued updated guidance on the use of taxanes for the treatment of breast cancer but says that its review of new evidence has not resulted in any changes to the original guidance issued in June 2000 (PJ, 24 June 2000, p942).

The guidance for fludarabine states that the drug can be introduced as therapy where patients with CLL would have been offered second line combination treatment of: cyclophosphamide, doxorubicin, vincristine and prednisolone; cyclophosphamide, doxorubicin and prednisolone; or cyclophosphamide, vincristine and prednisolone. It states that fludarabine is generally better tolerated than conventional second line chemotherapy regimens, particularly in patients considered too frail to withstand combination therapies. In addition, fludarabine is more clinically effective and cost effective than alternative second line therapies, says NICE.

NICE recommends that, unless contraindicated, oral fludarabine is given in preference to the intravenous formulation because it is more cost effective.

Andrew Dillon, chief executive, NICE, said: “Our guidance indicates that people with B-cell chronic lymphocytic leukaemia who have had to stop their first chemotherapy treatment, for example because it was causing side effects or their disease had progressed, should consider treatment with fludarabine.”

Commenting on the review of the taxane guidance, Mr Dillon said: “We have appraised all the evidence, including new evidence on the use of docetaxel in combination with doxorubicin for the treatment of advanced or metastatic breast cancer in patients who have not previously had cytotoxic therapy. The new evidence has not caused us to change our original guidance and therefore that advice stands.”

The full guidance reports are available on the NICE web site (www.nice.org.uk).