Quinupristin/ Dalfopristin (warning removed)
- One of this agent's approved indications is for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia.
- This agent has been approved for marketing in the United States for this indication under FDA's accelerated approval regulations that allow marketing of products for use in life-threatening conditions when other therapies are not available. Approval of drugs for marketing under these regulations is based upon a demonstrated effect on a surrogate endpoint that is likely to predict clinical benefit.
- Approval of this indication is based upon thi agent's ability to clear VREF from the bloodstream, with clearance of bacteremia considered to be a surrogate endpoint. There are no results from well-controlled clinical studies that confirm the validity of this surrogate marker. However, a study to verify the clinical benefit of therapy with this drug on traditional clinical endpoints (such as cure of the underlying infection) is presently underway.
Updated January 2018