FDA’s Pazdur: Accelerated Approval Is ‘Under Attack,' Supporters Can’t Afford To Remain Silent

US FDA’s Oncology Center of Excellence Director and the National Institutes of Health National Cancer Institute Director defended the agency’s accelerated approval pathway, saying critics are missing the benefits reaped by many cancer patients. Pazdur worries pathway is at risk, unless champions work to counter critics.

Reps. Diana DeGette, Fred Upton and Pazdur and Sharpless discuss Cures 2.0 — Cures 2.0 Congressional sponsors discuss expedited approval pathways with FDA’s Pazdur and NCI’s Sharpless • Source: Friends of Cancer Research

Accelerated approval is “under attack,” by critics who are “one-sided” and not taking a comprehensive look at the program, said Rick Pazdur, the director of the US Food and Drug Administration’s Oncology Center of Excellence.

Pazdur, speaking on 29 July at a Friends of Cancer Research event on the 21 Century Cures Act follow-up legislation...