FDA Gives Advice on Endotoxin Limits for Investigational Oncology Products
Trials of oncology products should limit endotoxin exposure, according to an FDA draft guidance released last week.
During early clinical trials, endotoxin limits of small molecule products or certain biologics administered parenterally should not exceed 5 USP-EU per kg body weight per hour, the guidance says.
For products with an intrathecal route of administration, the combined endotoxin exposure from all should not exceed 0.2 USP-EU per kg body weight per hour. If exposure does exceed that limit, sponsors should justify why the limit cannot be achieved and say why the risks to human subjects are “reasonable.”
The agency urges sponsors of products in late-stage development to tighten specifications to ensure that the combined exposure does not exceed the limit.
Read the full guidance here: https://bit.ly/39GLGWK.