USA – FDA addresses endotoxin levels in investigational cancer treatments

Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US Food and Drug Administration.

The draft guidance addresses the reality of oncologic drug development, where investigational therapies are frequently used in combination with other approved treatments, or in conjunction with another investigational drug. Specifically addressed are parenterally administered anticancer drugs under investigation to treat serious and life-threatening cancers.

“This guidance does not apply to the development of drugs for adjuvant or neoadjuvant treatment or for cancer subtypes that can be cured or where prolonged survival can be achieved with available therapy,” clarified the agency.

When an investigational drug is administered parenterally within 60 minutes of another approved drug, the endotoxin load may present a risk to the patient. Bacterial endotoxins can be contaminants of drugs and biologics; when introduced into the bloodstream or intrathecal space, the toxins can cause severe inflammatory reactions including high fevers and even septic shock and death…