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EMA approval for advanced non-melanoma skin cancer drug

12 Aug 2013
EMA approval for advanced non-melanoma skin cancer drug

Patients with a form of skin cancer that's spread or come back after treatment could benefit from a new drug that has been approved for use in the UK.

The European Medicines Agency (EMA) has authorised vismodegib to be used to treat advanced basal cell carcinoma (BCC).

BCC is the most common form of skin cancer in the UK, and is often found on the head and neck.

Most cases are relatively simple to remove with surgery.

But if left untreated, BCC can spread. In other cases, it can come back after surgery in a form that may no longer be suitable for further surgery or radiotherapy. This advanced form of the disease is relatively rare and affects around 700 people each year in the UK.

Vismodegib has been shown to shrink these advanced tumours in around half (47 per cent) of patients with locally advanced BCC that cannot be treated with surgery or radiotherapy.

It was also found to shrink tumours in around one third (33 per cent) of people with BCC that had spread to other parts of the body.

More than nine in 10 cases of basal cell carcinoma are caused by an abnormal change in a chemical process within cells, called the hedgehog cell signalling pathway. Vismodegib blocks this pathway.

The drug can also help patients with a condition called Gorlin syndrome, who regularly develop BCC throughout their lives due to an unherited fault in the hedgehog pathway in the cells of their body.

Research by Professor Phil Ingham, funded by Cancer Research UK, uncovered crucial detail about the hedgehog pathway, which led to the development of vismodegib.

Dr Harpal Kumar, Chief Executive of Cancer Research UK, said: "We are proud to have played a key role in the early development of this drug and we're delighted that it has passed this regulatory hurdle and is approved for use in the UK.

"This drug is a major advance for the treatment of this disease, providing advanced BCC patients with a new treatment option. This is great news for patients and it's thanks to the generosity of our supporters that we can invest in crucial early research which sparks advances like this."

Specialist doctors in England will be able to apply for vismodegib through the Cancer Drugs Fund, which has added the drug to its nationally approved list.

Professor Ruth Plummer, a Cancer Research UK clinician who was involved in some of the early trials of the drug, said: "If no longer treatable with surgery or radiotherapy, BCC can have a huge impact on someone's quality of life. Many men and women with the disease are elderly and can be become isolated if affected by disfiguring disease.

"Vismodegib will be a lifeline to these people. It's thanks not only to Cancer Research UK's lab work, but to fantastic collaboration between the network of Experimental Cancer Medicine Centers supported by the charity, which helped run the clinical trials."

She also said that vismodegib and other hedgehog inhibitors could one day be useful in other cancers too.

 

Source: CRUK