The draft MHRA guidance aims to clarify and streamline pathways
for bringing these therapies through to patients, without
compromising on robust safety principles.
The Medicines and Healthcare products Regulatory Agency (MHRA)
has today launched a consultation on
regulatory guidance for individualised mRNA cancer
immunotherapies (colloquially referred to as cancer vaccines).
This is an important step in bringing these promising therapies
closer to clinical practice.
The eight-week consultation was launched today 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.
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“We are asking all stakeholders to comment on draft guidance that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.”
Minister for Public Health, , said:
“More people than ever are being diagnosed with cancer so it's
vital that we push the boundaries of science to develop the
treatments of the future.
“Personalised immunotherapies could revolutionise our
approach by helping patients fight cancer cells in their
bodies.
“As government ramps up the use of groundbreaking technologies
and medicines across the board, this guidance will be
fundamental to achieving our goal of moving from sickness to
prevention. And it is yet another example of Britain leading
the way on cancer research, transforming cancer care to save
lives and support the NHS.”
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.
