The FDA is providing sponsors of cell therapies with a new draft guidance document on the kinds of safety testing they should perform.
The 14-page guidance, published late last month, provides sponsors with clarity on how to carry out cell safety testing when submitting an investigational new drug application or a biologics application. The guidance lays out how allogeneic cell therapies do carry some risk, including contamination, or genome changes that can potentially lead to cells developing into tumors.
The FDA says sponsors should base safety testing on the potential the cells have to expand, the reagents used to expand the cells and the number of patients capable of being treated.
Patrick HanleyPatrick Hanley, chief and director of cell therapy at Children’s National Hospital, told Endpoints News in an interview that the guidance is a sign the FDA is listening to cell therapy sponsors who have been asking the agency for more clarity in this area.
He said focusing on allogeneic cell therapies, which involve using cells from a donor to treat the patient, is particularly helpful. He said there wasn’t previously much clarity on the kind of testing that should be done based on the number patients being treated with the therapy.
“That’s what this guidance tries to address is what testing needs to be acquired based on the specific properties and treatment potential of the therapy,” he said.
Hanley added that it would be helpful if the FDA laid out benchmarks for testing based on the the specific number of patients being treated with a cell therapy, but acknowledged that would be difficult given that each therapy is different.
Comments on the guidance are due July 29.
The guidance lays out considerations for sponsors using highly expanded cells, as well as cells with limited potential to expand. It also includes a table with a description of types of cell therapies and their corresponding testing recommendations.