A recent press release from Northwest Biotherapeutics reveals their plans to submit a Marketing Authorization Application in the UK. This could lead to the treatment being available for commercial approval to treat Glioblastoma.
What is DCVax?
The DCVax-L immunotherapy treatment is a vaccine that is made using dendritic immune cells mixed with proteins from an individuals tumour cells. This vaccine helps the immune system to recognise and kill tumour cells more effectively.
We discussed results from a press release regarding the results of a multi-national phase 3 clinical trial testing the treatment last year. You can read last year’s press release here and also delve into what this means for our community by reading our commentary on the news.
The press release and future plans
As mentioned, North West Bio is preparing to submit a Marketing Authorization Application to the Medicines and Healthcare Products Regulatory Agency (MHRA).
The following information is from the press release:
The Company believes that it has now completed all of the remaining prerequisites for such an application, including certain steps related to implementation of the approved Pediatric Investigation Plan and submission of the required formal notification to the MHRA of the upcoming MAA. As the Company reported in its recent 10-Q filing, the Company is in the final stages of completing the application package itself.
The Company plans to submit the application by Mid-October. The application includes a request that it is reviewed under the 150-business day process established by the MHRA to make new medicines available faster for patients in the UK.
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If you or someone you love is living with a brain tumour and have any questions around this latest news, or want to access support, give us a call on 01983 292 405 or email firstname.lastname@example.org. You can also visit our little brainstrust website which features support for children affected by brain tumour.