NICE Upholds GlaxoSmithKline Appeal For Advanced Breast Cancer Treatment, Tyverb(R)(lapatinib)

Main Category: Breast Cancer
Also Included In: Cancer / Oncology
Article Date: 10 Jul 2009 - 1:00 PDT

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The National Institute for Health and Clinical Excellence (NICE) announced that, following GlaxoSmithKline's (GSK) appeal, it will reconsider the submission for Tyverb (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).1 GSK is pleased that NICE's appeal panel agreed that the draft negative guidance should be reviewed, providing fresh hope for up to 2,000 women in the UK who could benefit from this effective treatment on the NHS.

Dr Alison Jones, Medical Oncologist at the University College London Hospital and the Royal Free Hospital commented: "It is great that NICE will reconsider the evidence supporting the use of lapatinib as there is a significant unmet medical need for women with this aggressive form of advanced breast cancer. These women have very few treatment options left available to them and lapatinib, when combined with capecitabine, offers a chance of additional time without their disease progressing."

The appeal has been upheld in light of new supplementary NICE advice for the assessment of treatments in small patient populations with a short life expectancy, issued in January this year.2 The appeal panel agreed that GSK and other consultees should be given the opportunity to make a full submission under these new 'end of life' criteria.1

Simon Jose, General Manager, GSK UK commented: "We welcome the decision of the appeal panel and the opportunity to make a full submission to NICE under the end of life criteria. We appreciate that NICE has some very tough decisions to make, especially in this end of life setting, but given the considerable survival benefits that Tyverb offers these women, we believe it deserves full and thorough consideration."

In line with previous commitments, GSK UK will continue to offer the Tyverb Patient Access Programme to both NICE and individual NHS Trusts. Under this scheme GSK bears the cost of lapatinib for up to the first 12 weeks of treatment,

Safety Information

Lapatinib plus capecitabine is generally well tolerated. The most common adverse events associated with lapatinib plus capecitabine were diarrhoea, rash, nausea, vomiting, fatigue and hand-foot syndrome.3,4 Diarrhoea and rash were more common with the combination whilst the incidence of hand-foot syndrome was similar between the two treatment groups.3 A decrease in left ventricular ejection fraction (LVEF) was reported by 2.5% of patients receiving lapatinib plus capecitabine vs. 1% of patients on capecitabine alone.3 Hepatobiliary events (mainly raised liver enzymes and/or bilirubin levels) have been reported commonly in association with lapatinib plus capecitabine therapy.3 Lapatinib has also been associated with reports of pulmonary toxicity.

About Tyverb

• Tyverb received a conditional marketing authorisation in Europe, June 2008.3

• Tyverb, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive disease following prior therapy which must include anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.3

• Healthcare professionals should refer to the Tyverb Summary of Characteristics (SPC) for full prescribing information, including warnings and precautions.3

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

Tyverb® is a registered trademark of the GlaxoSmithKline group of companies.

References

1. Lapatinib for the treatment of women with previously treated advanced or metastatic breast cancer. NICE Appeal Panel's decision, 9 July 2009 http://guidance.nice.org.uk/TA/Wave13/1

2. Appraising life extending end of life treatments. January 2009. http://www.nice.org.uk/media/88A/F2/SupplementaryAdviceTACEoL.pdfAccessed 8 July 2009

3. Tyverb® (lapatinib) Summary of Product Characteristics. http://emc.medicines.org.uk/medicine/20929/SPC/Tyverb Last accessed 05 June 2009

4. Cameron D, Casey M, Press M, et al. A phase III randomised comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat 2008; 112:533-543

Source
GlaxoSmithKline