Brain cancer vaccine fast-tracked for UK patients
A brain cancer immunotherapy being developed by US company Northwest Biotherapeutics (NW Bio) is the first drug to be approved for early access under the UK's new fast-track programme.
NW Bio's vaccine - called DCVax-L - was given 'Promising Innovative Medicine' (PIM) status by the Department of Health (DH) on the back of data from two phase I/II trials in patients with glioblastoma, the most virulent form of primary brain cancer.
PIM status means that the vaccine can be approved for use by patients under the National Health Service (NHS) after a positive review of their safety and efficacy by the Medicines and Healthcare products Regulatory Agency (MHRA).
Ordinarily, drugs used by the NHS would also need approval from the European Commission as well as a review of their cost-effectiveness by the National Institute for Health and Care Excellence (NICE) in England and Wales or the Scottish Medicines Consortium (SMC).
PIM is in some ways analogous to the breakthrough status awarded by the US Food and Drug Administration (FDA), as well as the EU's adaptive licensing project, and represents the initial step in the UK's Early Access to Medicines Scheme (EAMS) which was launched in April.
The EAMS "offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally reach them," according to the DH.
NW Bio will now be eligible to apply for the second stage of the EAMS if DCVax-L is successful in clinical trials, potentially making the vaccine available to patients ahead of formal licensing.
The PIM scheme "strikes a very practical balance between clinical benefits and risks, through careful scientific evaluations, and will be of great help to doctors and patients in opening up new treatment options," said NW Bio's chief executive Linda Powers.
NW Bio's DCVax platform is based on the use of activated dendritic cells - which it describes as the master cells of the immune system - and is designed to "reinvigorate and educate the immune system to attack cancers," according to the company.
Following Germany's lead
DCVax-L has already been granted permission to be sold under an early access scheme in Germany known as a 'hospital exemption' which means it can be made available for a five-year period while trials are being conducted.
The vaccine was also the first drug to be approved under the German process, operated by the Paul-Ehrlich-Institute (PEI), which said it could used after patients receive the standard therapy for the brain cancer based on surgery, radiotherapy and chemotherapy with Merck & Co's Temodar temozolomide).
In March, NW Bio said it was ramping up manufacturing of DCVax-L in order to start selling the drug before the end of the year, once reimbursement negotiations with the German authorities are concluded.
Life Sciences Minister George Freeman said the PIM is the first, crucial step in developing cutting-edge medicines sooner, giving real hope to patients and their families.
"We want to make Britain the best place in the world to design and deliver 21st Century healthcare technologies which is central to our life science strategy."
