FOI release
Third-Party Submissions Concerning DCVax-L / Individualised Cancer Immunotherapy
This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.
Case reference FOI2026/01041
Received 11 September 2026
Published 9 October 2026
Request
I am requesting information under the Freedom of Information Act concerning third-party submissions or communications relating to Northwest Biotherapeutics’ Marketing Authorisation Application (MAA) for DCVax-L, submitted on 20 December 2023. I am particularly interested in whether individuals, patient groups, healthcare professionals, companies, organizations, or other third parties have submitted questions, concerns, objections, or other substantive representations concerning DCVax-L to the MHRA, including in connection with the MHRA’s 2025 consultation concerning individualised cancer immunotherapies. Specifically, I would like to know: 1. Whether the MHRA received any substantive third-party submissions concerning DCVax-L or Northwest Biotherapeutics’ MAA during the period 20 December 2023 to the present. 2. If so, the approximate number of such submissions and, where disclosure is possible, the broad category of the source (for example: patient/patient group, healthcare professional, academic, competing commercial interest, industry organization, or other). 3. Whether any such third-party submissions were provided to, referred to, or otherwise considered by the MHRA team responsible for assessing the DCVax-L MAA. 4. Whether any such third-party information or concerns resulted in, contributed to, or were associated with additional questions or Requests for Information (RFIs) being sent to Northwest Biotherapeutics. 5. If the answer to (4) is yes, the number and approximate dates of those RFIs and a general description of the subject matter, excluding commercially confidential or personally identifiable information. 6. Whether the MHRA maintains records specifically identifying third-party communications that were considered material to the regulatory assessment of the DCVax-L MAA. I am not requesting personal information, confidential identities, commercially sensitive material, or the contents of confidential regulatory correspondence. If any portion of the information requested is exempt from disclosure, I would appreciate disclosure of the remaining non-exempt information, including aggregate numbers, dates, categories of sources, and general subject matter where possible. If the request is considered too broad, please identify the specific part that creates the difficulty and advise how it could be narrowed rather than treating the entire request as refused.
Response
See attached
Documents
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