Unsafe and unregulated cell therapies being sold in Europe
The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European Union. Dendritic cell therapies have shown promise in cancer treatment, but have not yet been approved by the EMA.
The European Medicines Agency (EMA) has issued a warning about the dangers of unregulated advanced therapy medicinal products (ATMPs) being illegally offered to patients in Europe. ATMPs encompass a wide range of treatments including those that are based on cells, genes, or tissues. Advanced therapies have become a promising option in recent years to treat rare diseases and certain types of cancer.
Whilst the EMA has approved multiple products for patient use, the agency said that individuals, companies, and clinics are also marketing unregulated ATMPs. There is little to no evidence these unregulated products work and can cause serious side effects, putting patients at risk. The EMA said that sellers exploit patient distress, selling treatments on websites or social media channels “as a last hope.”
A particular modality highlighted by the agency was dendritic cell therapies, a form of immunotherapy that has shown some promise in treating cancers. The therapy uses the patients’ own dendritic cells to initiate an immune response and attack cancer cells. Dendreon Pharmaceuticals used to make the only EMA-approved dendritic cell therapy called Provenge (sipuleucel-T), which received marketing authorisation in 2013. However, approval was withdrawn in May 2015 by Dendreon citing its poor commercial performance. The vaccine is still available in the US.
“It is important that patients are only offered ATMPs, including dendritic cell therapies, that have been authorised or approved by a regulator,” the EMA said in a statement.
The warning by the EMA is not the only instance in recent times that a health agency has had to clamp down on unregulated medicinal products. The World Health Organization (WHO) issued an alert in June last year relating to falsified batches of popular type 2 diabetes drug Ozempic (semaglutide). The agency said the unregulated products could have harmful effects on patient health.
