The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking input on its draft guidance for developing individualized messenger ribonucleic acid (mRNA) cancer immunotherapies. The agency said that research into the treatments is advancing rapidly, and it wants to ensure its premarket pathways are prepared to allow such products on the market.
Since the technology was successfully used to develop COVID-19 vaccines, drugmakers have sought to apply it in new therapeutic areas, with oncology being a major focus.
“Individualized 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, » said Julian Beach, MHRA executive director of healthcare quality and access. « Because these treatments are tailored to an individual’s tumor, they pose unique scientific questions on how they should be regulated.”…
