The Medicines and Healthcare Products Regulatory Agency (MHRA) has opened a consultation on regulatory guidance for personalized mRNA cancer immunotherapies (also known as cancer vaccines). This is a critical step in bringing these potential therapies into clinical practice. The guidance intends to expedite the paths for delivering these medicines to patients while maintaining strong safety principles.
The eight-week consultation was launched 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.
Individualized mRNA cancer immunotherapies are the first type of cancer treatment that employs mRNA technology. In the body, mRNA functions as a messenger, instructing cells on how to produce a specific protein. Specific mRNA molecules employed in treatments can instruct the body how to fight diseases.
Unlike traditional cancer therapies, these medications provide each patient with a version of the mRNA therapy that has been artificially intelligently matched to their unique tumour fingerprint. In this method, the therapy seeks to train the patient's immune system to target and destroy specific tumor 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 includes product design and manufacturing, evidence required to demonstrate safety and effectiveness, and post-approval safety monitoring. The MHRA intends to broaden the guidance in the future to include other types of highly personalized medicines, including those for uncommon diseases. The Highly Personalised Medicines Expert Working Group of the Commission on Human Medicines, which includes patient specialists, provided independent scientific input in the development of this recommendations.
