The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on regulatory guidance for individualised mRNA cancer immunotherapies, also known as cancer vaccines, marking a significant step towards making these promising therapies more accessible for clinical use.
The consultation, which began on February 3 and will run for eight weeks, invites input from stakeholders, including the developers of these medications, to provide feedback for the guidance to be updated. The MHRA is also welcoming comments from the public, including individuals impacted by cancer.
The primary goal of the guidance is to create a streamlined pathway for the introduction of these therapies to patients while upholding safety standards. Julian Beach, MHRA Executive Director of Healthcare Quality and Access, emphasized the importance of individualised cancer immunotherapies and the need for tailored regulatory approaches due to their unique nature.
Individualised mRNA cancer immunotherapies utilize mRNA as a messenger to instruct cells on producing specific proteins, which can aid in fighting diseases when formulated into medications. Each patient receives a personalized version of the therapy matched to their tumor profile using AI, with the aim of training the immune system to target and eliminate specific cancer cells.
With the guidance in place, the MHRA aims to simplify patient access to these innovative cancer treatments by outlining a clear regulatory pathway for approval. The guidance addresses various aspects, including product design, manufacturing processes, required evidence for safety and efficacy, and post-approval safety monitoring.
Furthermore, the MHRA intends to extend this guidance to cover other types of personalized therapies, including those for rare diseases, in the future.
(Source: UK MHRA)
