Northwest Biotherapeutics’ DCVax-L Chosen for New UK Fast-Track Access Scheme
Northwest Biotherapeutics’ new experimental cancer jab, DCVax-L, is the first medicine to be approved by the UK’s new fast-track access programme for early use.
The cell therapy has received ‘Promising Innovative Medicine’ (PIM) designation, which is the initial step in the new Early Access to Medicines Scheme (EAMS).
The cancer jab ‘retrains’ a patient’s immune system to recognise and attack cancer cells. The PIM designation covers the treatment of malignant melanomas, including the most severe form Glioblastoma multiforme, as well as newly diagnosed and recurrent cases.
Keyoumars Ashkan, a senior neurosurgeon at Kings College Hospital in London, commented that “it is encouraging to see this innovative new product be the first to receive certification as a PIM under the new EAMS.”
The scheme is aimed at offering promising new drugs to patients with life-threatening or seriously debilitating conditions earlier than normal, once the Medicines and Healthcare products Regulatory Agency (MHRA) has decided that benefits of the drug outweigh any risks.
The ‘Promising Innovative Medicine’ designation also operates as an initial signal to healthcare companies that a development plan is on the right track, indicating that the drug could be a candidate for the EAMS when additional required work has been conducted.
Life Sciences Minister, George Freeman noted that the “PIM designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families.”