The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on regulatory guidance for individualised mRNA cancer immunotherapies (cancer vaccines).

The guidance aims to streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles. The eight-week consultation will run until 31 March.

Julian Beach, MHRA executive director of healthcare quality and access, explained: “Individualised cancer immunotherapies, while still being tested in clinical trials, are an exciting development in our hunt to find new and better ways to treat cancer. Because these treatments are tailored to an individual’s tumour, they pose unique scientific questions on how they should be regulated.”

Individualised mRNA cancer immunotherapies are a new type of cancer treatment that uses mRNA technology. 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.

The draft guidance covers product design and manufacture, evidence needed show safety and effectiveness, and post-approval safety monitoring.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 personalised therapies, including those for rare diseases.