An experimental cancer jab being developed by US group Northwest Biotherapeutics is the first medicine to be approved for early use under the UK’s new fast-track access programme.
The cell therapy DCVax-L has received the first ever 'Promising Innovative Medicine' (PIM) designation, marking the first step in the new Early Access to Medicines Scheme (EAMS).
The Scheme is designed to offer patients with life-threatening or seriously debilitating conditions the chance to receive innovative and promising new drugs much earlier than normal, as soon as the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the benefits outweigh the risks.
The PIM also serves as an early signal to companies that a development plan is on the right track, indicating that a product could be a candidate for the EAMS when further necessary work has been conducted. According to the Department of Health, this early boost to a drug’s potential should benefit companies, especially small and medium-sized enterprises who can struggle to attract capital during drug development.
“This PIM designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families,” commented Life Sciences Minister George Freeman, and he said the scheme “is helping to secure a better future for people and proves that our country is leading the world in Life Sciences”.
Difficult-to-treat brain cancers
DCVax-L works by ‘retraining’ an individual’s immune system to recognise and attack cancer cells and, according to the firm, has the potential to treat many solid tumour cancers. It’s PIM, however, specifically covers the treatment of malignant melanomas, including the most severe form Glioblastoma multiforme, as well as newly diagnosed and recurrent cases.
“DCVax-L offers an exciting new approach to treating these brain cancers, through personalised immune therapy,” said Keyoumars Ashkan, a senior neurosurgeon at Kings College Hospital in London, and noted “it is encouraging to see this innovative new product be the first to receive certification as a PIM under the new EAMS”.