An experimental cell therapy for brain tumours is the first medicine to be selected for fast-track designation under a new early access scheme in the UK, the Department of Health (DH) announced on 16 September 2014.
The product, known as DCVax-L and developed by US firm Northwest Biotherapeutics, works by retraining an individual’s immune system to recognise and attack cancer cells.
It has been awarded ‘promising innovative medicine’ status, the first step in the UK’s early access to medicines scheme (EAMS) that was launched in April 2014 and allows access to novel drugs before they are officially licensed for sale. DCVax-L’s designation covers all malignant gliomas, both newly diagnosed and recurring.
The EAMS is intended to make groundbreaking new medicines available to severely ill patients with life-threatening conditions much earlier than would normally be the case. It provides an early signal to companies that their development plans are on the right track and can be beneficial to small and medium-sized enterprises, which can struggle to attract capital during drug development.
If DCVax-L trials are successful, the company will be able to apply for a scientific opinion, which, if positive, means patients can access the new drug while the company continues to collect data.