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5-ALA gets FDA approval

The United States’ Food and Drug Administration (FDA) has approved the use of aminolevulinic acid hydrochloride as an optical imaging agent for use in people affected by high grade gliomas.

5-Aminolevulinic Acid (5-ALA), is a surgical intervention in the form of a drug given to patients with certain types high grade (malignant) brain tumours ahead of surgery. Known informally as the ‘pink drink’, 5-ALA makes brain tumour cells illuminate under fluorescent light.

The United States’ Food and Drug Administration (FDA) has now approved the use of aminolevulinic acid hydrochloride as an optical imaging agent for use in people affected by high grade gliomas.
However, people affected by a high grade brain tumour in the UK face a post-code lottery with 5-ALA. The EU has already approved its use in high grade gliomas, however it is only currently available in around half of neurosurgery units in the UK. Whilst the FDA’s decision has no direct relevance to its use in the UK the news is a welcome validation of the benefits of the drug.

There are few treatment options for people affected by a high grade brain tumour and prognosis and quality of life are poor. There is also a tremendous burden on those affected. Brain tumours are the biggest cancer killer of under 40s and reduce life expectancy by, on average, 20 years – the highest of any cancer.

A panel of experts included 5-ALA in our Patient Guide, which outlines the standards of care we believe all adults diagnosed with a brain tumour should expect from the NHS. Surgical care and management is critical and the extent of tissue removal is the only factor surgeons can influence to improve survival. Evidence shows that 5-ALA improves the removal of tumour tissue and delays worsening progression of the disease.

We believe that there should be fair and equal access to 5-ALA where clinically appropriate. The NHS owes it to those affected to provide the best standard of treatment and care possible. Surgeons must have access to the tools which can make a difference and give people affected a better outcome.

If you or someone you know has recently been diagnosed with a high grade brain tumour we urge you to have a conversation with your clinical team about 5-ALA. Look to our Information Pack for more details.

Get involved with our Policy and Campaigns Team to help us deliver equal access to the best treatment and care for brain tumours across the UK.

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