The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on regulatory guidance for individualised mRNA cancer immunotherapies (colloquially known as cancer vaccines). This is an important step in bringing these promising therapies closer to clinical practice.
During the eight-week consultation (launched on February 3), stakeholders, including the developers of these medicines, will need to provide comments, after which the guidance will be updated. The UK regulator also welcomes comments from the public, including people affected by cancer.
The guidance aims to streamline pathways for bringing these therapies to patients, without compromising on safety principles.
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.”
In individualised mRNA cancer immunotherapies, the mRNA acts as a messenger in the body, instructing cells on ways to make a specific protein. In the form of medicines, specific mRNA molecules can teach the body how to fight diseases.
Unlike in conventional cancer therapies, here each patient receives a version of the mRNA therapy that is matched to their unique tumour fingerprint using artificial intelligence (AI). The therapy aims to teach the patient’s immune system to target and destroy specific tumour cells.
With the 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 to show safety and effectiveness, and post-approval safety monitoring.
The MHRA aims to expand the guidance to other types of personalised therapies, including for rare diseases.
(Source: UK MHRA)