The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "Individualised mRNA Cancer Immunotherapies", commonly referred to as personalised cancer vaccines. This consultation, launched on 3 February 2025, seeks feedback from various stakeholders, including manufacturers, developers, patient organisations, and individuals affected by cancer. The aim is to refine and streamline the regulatory pathway for these innovative therapies without compromising safety standards.
Individualised mRNA cancer immunotherapies represent a novel approach to cancer treatment. Unlike traditional therapies, these treatments are tailored to each patient's unique tumour profile.
By utilising mRNA technology, these therapies instruct the patient's immune system to target and destroy specific cancer cells. This personalised method holds promise for more effective and targeted cancer treatments.
The draft guidance addresses several critical areas to facilitate the development and approval of these therapies:
Product Design and Manufacture: Guidelines on ensuring consistent and safe production processes tailored to individual patient needs.
Evidence of Safety and Effectiveness: Criteria for demonstrating the safety and efficacy of these personalised treatments through clinical trials and studies.
Post-Approval Safety Monitoring: Strategies for ongoing monitoring of patients to promptly identify and manage any adverse effects.
Information for Patients and the Public: Recommendations on effectively communicating the benefits and risks of these therapies to patients and the broader public.
The MHRA emphasises the importance of clear regulatory pathways to expedite patient access to these therapies while maintaining rigorous safety standards.
The MHRA is actively seeking input from a broad spectrum of stakeholders to ensure the guidance is comprehensive and effective. Feedback is particularly encouraged from:
Manufacturers and developers involved in creating these therapies.
Patient organisations advocating for those affected by cancer.
Healthcare professionals administering cancer treatments.
Members of the public, especially individuals impacted by cancer.
The consultation period is open until 31 March 2025. Stakeholders are invited to review the draft guidance and submit their comments within this timeframe.
Stakeholders can access the document and submit their feedback through the following link:
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