In the News: Glioblastoma vaccine to be reviewed for licensing in the UK

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A vaccine shown to prolong life in patients diagnosed with the most common high-grade brain tumour affecting adults is to be reviewed for approval for use in the UK. 

Northwest Biotherapeutics, a biotechnology company developing DCVax® personalised immune therapies for solid tumour cancers, has announced it has submitted a Marketing Authorisation Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for DCVax®-L for new and recurrent glioblastoma (GBM). 

DCVax®-L trains the cells of a patient’s immune system (dendritic cells) to recognise the cells that make up a GBM tumour. This enables the immune system to identify and attack tumour cells helping to reduce the tumour’s size and hamper its progression. 

Northwest Biotherapeutics’ application to the MHRA follows the results of an international Phase 3 clinical trial which demonstrated a meaningful extension of median survival in both newly diagnosed and recurrent GBM in patients treated with DCVax®-L. Read more in our Emerging Therapies blog.   

The application seeks approval for the commercialisation of DCVax®-L for both newly diagnosed and recurrent GBM, and requests to be considered under the MHRA’s rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs.  

The MHRA is part of the Department of Health and is responsible for regulating medicines, medical devices and blood donation for transfusions within the UK. All medicines and medical devices must obtain a Marketing Authorisation from the MHRA to ensure that they are safe and effective before they can be prescribed or sold within the UK. It is usually following a successful MHRA application that a new medicine will be reviewed by the National Institute for Health and Care Excellence (NICE), which considers clinical effectiveness and value for money before recommending its use on the NHS. 

Dr Karen Noble, our Director of Research and Policy said: “We are excited about the promise of new treatment options for brain tumour patients who have been waiting for nearly 20 years.  

“For more therapies to make it to market, more funding needs to be invested in research into brain tumours. Without sustainably funded, high-quality research, patients will not see the improvement in outcomes that they so desperately deserve.” 

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