This month sees a milestone in treatment for glioblastoma (GBM). Northwest Biotherapeutics presented the results of the completion of its clinical trial for DCVax at a scientific conference this month. This phase 3 trial enrolled 331 patients from 94 trial sites across the UK, Germany, USA and Canada. Phase 3 is the final phase in the clinical trial process prior to seeking regulatory approval (enabling doctors to prescribe). The last patient was enrolled in November 2015 and long term survival has been followed up to determine the survival “tail”.
Both endpoints were met with statistical significance. This means that DCVax®-L made a difference to the overall survival for some patients with newly diagnosed GBM and recurrent GBM. This is significant news for the brain cancer community and at last gives hope. Completion of the clinical trial brings DCVax®-L closer to being made available as a treatment for those patients for whom it is appropriate, subject to regulatory approval. NWBio is working hard and fast to make this happen.
The next step would be to seek regulatory approval e.g. from MHRA. If MHRA approves the therapeutic vaccine, then the final step is negotiation with the National Institute for Health and Care Excellence (NICE) for reimbursement and delivery through NHS.
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