Regulatory Focus™ > News Articles > UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance

UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance

Posted 27 April 2012 | By Louise Zornoza

The National Institute for Health and Clinical Excellence (NICE) will not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors for a particular type and stage of breast cancer, the agency said in a final draft guidance issued 26 April.

The proposal notes that it is unclear how much either drug can improve overall survival compared to existing treatments and that the drugs do not appear to represent value for money for the National Health Service (NHS).

The final draft document follows a consultation in February 2012 on NICE's provisional recommendation. The guidance covers the use of lapatinib or trastuzumab specifically as first line treatment options to delay the growth of advanced breast cancer that has spread to other parts of the body (metastatic disease), and which reacts with the hormones oestrogen or progesterone and has high levels of a protein called HER2 on the surface of its cells.

If women are already receiving either option when the final guidance is published, then they should be able to continue treatment until they and their doctors consider it appropriate to stop.

Estimates of the number of postmenopausal women diagnosed with this type and stage of breast cancer every year ranged from 50 to 2000. It is believed that most women with HER2 positive breast cancer are likely to be offered trastuzumab alongside chemotherapy as their first line option - this NICE appraisal does not look at the use of trastuzumab in this way.

Lapatinib or trastuzumab would usually be considered as first line options alongside aromatase inhibitors only when chemotherapy is deemed unsuitable; however, it is unclear for how many women this would be relevant. Taking aromatase inhibitors in isolation is another existing option for these women.

Read more:

NICE - Breast cancer (metastatic hormone-receptor) - lapatinib and trastuzumab (with aromatase inhibitor): final appraisal determination 2

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