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Roche's Erivedge authorised in UK

Available for skin cancer patients through Cancer Drugs Fund

Roche Basel Switzerland

Patients with basal cell carcinoma (BCC) in the UK may soon be able to access treatment with Roche's Erivedge, the first drug licensed in the EU for advanced forms of this common skin cancer.

Roche's UK subsidiary said today the UK had given a green light to use of the drug following its conditional approval by the European Medicines Agency (EMA) last month as a once-daily, oral treatment for use in patients with advanced BCC who are not suitable for treatment with surgery or radiotherapy.

Erivedge (vismodegib) - originally developed by Curis - has also been listed in the national Cancer Drugs Fund (CDF), so patients in England may be able to secure funding treatment with Erivedge ahead of approval by the National Institute for Health and Care Excellence (NICE).

BCC is the most common form of skin cancer and typically is found on the head and neck and while many in the early stages can be successfully treated with surgery or radiotherapy, there are few effective therapies available for more advanced cases.

In trials, vismodegib shrank visible lesions in 47 per cent of patients with locally BCC and in a third of patients whose disease had metastasised to other parts of the body. The drug was also associated with progression-free survival (PFS) of 9.5 months.

The advanced form of the disease affects up to 700 people a year in the UK, according to Roche's UK subsidiary. The company is committed to completing an ongoing safety study before approval in the EU becomes non-conditional.

"Advanced BCC can be a socially isolating and highly disfiguring disease that may impair patients' facial structures and senses," commented consultant dermatologist Dr John Lear of Salford Royal NHS Foundation Trust.

"Vismodegib, which has been shown to shrink tumours, is a welcomed new treatment option for patients with advanced BCC and should provide them with a promising new outlook," he added.

Vismodegib works by targeting a molecular process inside cells known as the 'hedgehog' signalling pathway, whose precise functioning was unravelled by Cancer Research UK scientists in the 1990s.

Erivedge is also approved for use in patients with advanced BCC in the US, Australia, Israel, Mexico, and South Korea, and Roche recorded sales of around $16m for the product in the second quarte; a 22 per cent increase over the first three months of the year, according to Curis.

Roche also recently completed a phase II trial of Erivedge in non-recurring operable modular BCC, which is a less severe form of the disease.

Article by
Phil Taylor

12th August 2013

From: Sales

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