Progression-free survival (PFS) is a perfectly reasonable basis for the US Food and Drug Administration (FDA) to approve new drug indications, according to ONI readers. Of those who responded to ONI’s July poll question—“Should FDA accept progression-free survival as a basis for approval of new drug indications?”--half (50%) answered in the affirmative.
The poll was linked to the article, “Bevacizumab improves PFS in advanced breast cancer.” Bevacizumab (Avastin) received FDA approval as first-line therapy with paclitaxel for HER2-negative metastatic breast cancer based on improved PFS in the E2100 trial (July 2008, page 28).
PFS is second only to response rate as the most frequently employed endpoint for oncologic drug approval, according to Richard Pazdur, MD, director of FDA’s Office of Oncology Drug Products “Cancer drugs pipeline is healthy, says head of oncologic drug approval for FDA,” (August 2008, page 24).
To respond to this month’s poll question on reimbursement (page 2), visit cancernetwork.com.