1. Pink Sheet

UK MHRA Consults On The Way For Personalized mRNA Cancer Therapies

 
• By Eliza Slawther

The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.

Cancer mRNA immunotherapies pose unique regulatory questions (Shutterstock)
Key Takeaways
  • The UK’s MHRA is requesting stakeholder feedback on draft regulatory guidance for individualized cancer mRNA immunotherapies.
  • The MHRA is taking a proactive stand on regulating these therapies, given that they are still in the clinical development stage.
  • The guidance includes information on the manufacturing, evidence generation and post-market safety monitoring of these novel cancer therapies.

Individualized cancer mRNA immunotherapies, also known as cancer vaccines, have the potential to “revolutionize” cancer care, according to the UK’s Medicines and Healthcare products Regulatory Agency.

On 3 February, the agency released a 34-page draft guidance document for developers of individualized mRNA cancer immunotherapies, focusing on the regulatory and scientific challenges specific to these products.

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