A new immunotherapy for a form of brain cancer has become the first in the UK to be designated a ‘Promising Innovative Medicine’ (PIM) as part of a scheme to speed up access to experimental new treatments.
Manufacturer Northwest Biotherapeutics said the treatment was given PIM status as part of the UK Government’s Early Access to Medicine scheme.
The scheme has been set up to help people who have exhausted all other treatment options – including those with advanced cancer, and other serious illnesses like dementia – gain access to drugs that have shown promise in clinical trials but are not yet fully licensed.
DCVax-L is the first such therapy to be designated a PIM since the project was launched in March.
The treatment utilises a patients’ own immune cells – mixed with proteins from a sample of their brain tumour – to generate a treatment that can help the immune system recognise and target the cancer cells.
Recruitment for a phase III clinical trial of the treatment is also underway, and set to close at the end of this month.
New medicines only receive PIM status once they have passed important safety criteria.
Following this approval a drug must then progress to the next phase of the Early Access to Medicines scheme where the Medicines and Healthcare products Regulatory Agency (MHRA) will carry out a scientific assessment of the treatment’s advantages and risks.
If the MHRA believes there are more advantages than disadvantages, the drug will be made available to patients.
Although patients will be able to access treatments via this scheme, drugs will still also go through the normal licensing process and then be assessed by The National Institute for Health and Clinical Excellence (NICE).
Emma Greenwood, head of policy development at Cancer Research UK, said: “We’re delighted that this scheme could give patients fast-track access to a potential new brain cancer vaccine.
“Time is vitally important and can mean the difference between life and death for manycancer patients, particularly those whose disease is advanced.
“This scheme aims to ensure that patients can be treated with promising new medicines faster, and it’s also likely to attract life science companies to the UK and encourage them to develop new drugs here.”
Life Sciences Minister George Freeman said: “This Promising Innovative Medicine designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families.”