The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on regulatory guidance for individualised mRNA cancer immunotherapies (colloquially referred to as cancer vaccines).
The eight-week consultation was launched Monday 3 February and will run until 31 March 2025. The MHRA is asking all stakeholders, including developers of these medicines, to provide comments, after which the guidance will be updated. The UK regulator also welcomes comments from members of the public including people affected by cancer.
The guidance aims to streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles. This is an important step in bringing these promising therapies closer to clinical practice.
Julian Beach, MHRA Executive Director of Healthcare Quality and Access said: “Individualised cancer immunotherapies, while still being tested in clinical trials, are a very exciting development in our hunt to find new and better ways to treat cancer, which is a leading cause of death worldwide. Because these treatments are tailored to an individual’s tumour, they pose unique scientific questions on how they should be regulated.”
June Raine, MHRA Chief Executive said: “As an enabling regulator, we do not wish to keep patients waiting unnecessarily for important new medicines such as personalised immunotherapies. We are asking all stakeholders to comment on draft guidance that addresses the questions this new regulatory pathway raises.”
Individualised mRNA cancer immunotherapies are a new type of cancer treatment that use mRNA technology. mRNA acts as a messenger in the body and tells cells how to make a specific protein. When used in medicines, specific mRNA molecules can teach the body how to fight diseases. Unlike conventional cancer therapies, for these medicines each patient receives a version of the mRNA therapy that has been matched to their unique tumour fingerprint using artificial intelligence (AI). In this way, the therapy aims to teach the patient’s immune system to target and destroy their specific tumour cells.
These highly innovative therapies are currently in clinical trials. They pose unique questions on how they should be safely regulated. With this guidance, the MHRA aims to facilitate patient access to these novel individualised cancer therapies by outlining a clear and streamlined regulatory pathway to approval.
The guidance covers product design and manufacture, evidence needed show safety and effectiveness, and post-approval safety monitoring. The MHRA aims to expand the guidance in due course to cover other types of highly personalised therapies, including for rare diseases.
This guidance has been developed with independent scientific advice from the Highly Personalised Medicines Expert Working Group of the Commission on Human Medicines, including patient experts.
To read the draft guidance and complete the survey – click here.