First therapy under UK’s early access scheme to be Northwest Biotherapeutics’ DCVax-L

The UK’s Department of Health announced that DCVax-L, the dendritic cell-based vaccine from US company Northwest Biotherapeutics (Nasdaq: NWBO), will be the first drug to be awarded Promising Innovative Medicine (PIM) status, covering all malignant gliomas, including glioblastoma multiforme.

This designation marks the first step under the UK’s Early Access to Medicines Scheme (EAMS), modelled on the US Food and Drug Administration’s breakthrough therapy designation, which is aiming to give seriously ill patients access to drugs ahead of when they would normally receive them.

The scheme was launched this March, funded by drugmakers, and is awarded after the assessment of early clinical data by the Medicines and Healthcare Products Regulatory Agency (MHRA) has indicated that a product could be a candidate for the EAMS after further development.