The UK health watchdog, the National Institute for Health and Clinical Excellence (NICE), the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health, earlier today published the outcome of an appeal hearing relating to its draft guidance on the use of lapatinib (Tyverb?, GlaxoSmithKline) for certain breast cancer patients.

Lapatinib is an oral drug that works by blocking signals from a number of receptors that lie on the surface of some cells in the body, including the HER2 receptor. By blocking these ?signals’, the drug stops cancer cells growing and spreading.

The current draft guidance recommends lapatinib, in combination with capecitabine (Xeloda?, Roche), for people with advanced or metastatic HER2-positive breast cancer but only in the context of clinical trials. NICE subsequently received one appeal from GlaxoSmithKline and this was heard by an independent appeal panel.

The draft guidance states that lapatinib, in combination with capecitabine, is not recommended for the treatment of women with HER2-expressing, advanced or metastatic breast cancer that has progressed following treatment with anthracyclines, taxanes, and trastuzumab in the metastatic setting, except in the context of clinical trials. However, the NICE advisory commitee recommended that women who are currently receiving lapatinib should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

?However, we have decided not to issue guidance at this stage. This is because we now believe that a better way of assessing the value of lapatinib is to consider it alongside the use of trastuzumab (Herceptin?, Roche) beyond progression (in other words, beyond the point at which, even after using trastuzumab, the disease begins to get worse). Even though trastuzumab isn’t licensed for this, it is frequently being used in this way in the NHS. We think that it is in the interests of patients – and the NHS – to fully consider what effect using lapatinib in these circumstances might have on the use of NHS resources. We have asked the Department of Health for permission to carry out an appraisal on the use of trastuzumab for advanced and metastatic breast cancer and lapatinib together. This will include the continuing use of trastuzumab post-progression. If the Department of Health gives permission, the Institute will carry out this appraisal as quickly as possible. In the meantime, patients who are currently receiving lapatinib can carry on doing so and NHS bodies will be expected to make decisions locally on the funding and choice of treatments.?

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NICE’s clinical guideline on early and locally advanced breast cancer currently recommends two approaches to the use of trastuzumab when the disease progresses, specifically for (first) patients who are receiving treatment with trastuzumab for advanced breast cancer, discontinue treatment with trastuzumab at the time of disease progression outside the central nervous syste and (second) patients who do not discontinue trastuzumab if disease progression is within the central nervous system alone.

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