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'Personalised' skin cancer drug wins NICE approval

22 September 2014
Appeared in BioNews 772

A skin cancer drug designed to be effective in patients whose cancer is driven by a specific gene mutation has been recommended by the National Institute for Health and Care Excellence (NICE) to treat patients with advanced melanoma.

Dabrafenib, which is marketed as Tafinlar by GlaxoSmithKline, blocks the growth of cancerous cells containing the BRAF V600 mutation, which has been linked to half of all aggressive melanomas.

The mutation, which can be triggered by ageing and overexposure to the sun, was confirmed in 2009 (see BioNews 503) as the first event in a cascade of genetic changes that eventually lead to the development of melanoma.

In 2012, NICE recommended two BRAF V600 mutation-targeting drugs: vemurafenib and ipilimumab (see BioNews 680), after they were shown to improve both quality and quantity of life for certain patients with advanced melanoma in clinical trials (see BioNews 660).

Professor Carole Longson, director of the centre for health technology evaluation at NICE, said: 'Drugs like dabrafenib are thought to have very rapid positive effect for patients, even in those who are very unwell or bedridden. In some cases, it has enabled people to resume everyday activities'.

Malignant melanoma is the fifth most common cancer among 15-to-34-year-olds in the UK and cases have increased by over 50 percent in the last decade. Early melanomas can often be surgically removed, slowing or halting disease progression, however treatments for advanced-stage melanoma remain limited.

Dabrafenib is being recommend for advanced-stage patients who test positive for the mutation and where it is no longer possible to have the cancer removed surgically.

'While the drug does not provide a cure, it represents the progress made in our understanding of biology in advanced skin cancer and how this can be used to develop innovative treatments to treat the disease', Professor Peter Johnson, Cancer Research UK's chief clinician, told BBC News.

Although the trials of BRAF V600-targeting treatments confirmed their effectiveness, drug resistance remains a concern in the long run.

Professor Paul Workman, interim chief executive of the Institute of Cancer Research in London, said: 'One drawback of dabrafenib and vemurafenib is that although they are often initially very effective, cancers usually become resistant to treatment within a year'.

'One very promising area of our research is the design of so-called panRAF inhibitors, which are intended to be effective against BRAF and other cancer mutations simultaneously. We hope that this new type of targeted drug could further expand the currently very limited treatment options for advanced melanoma'.

Green light for new skin cancer drug
BBC News |  18 September 2014
Skin cancer drug should be available on NHS, officials say
The Guardian |  18 September 2014
Skin cancer drug with 'rapid positive effects' is recommended for use on the NHS
MailOnline |  18 September 2014
Statement in response to NICE approval of dabrafenib for the treatment of certain cases of advanced melanoma
Institute of Cancer Research (press release) |  17 September 2014
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