The Greatest FDA Advisory Committees, Part II: The Birth Of The ‘Pazdur Moment’
With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.
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Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.
FDA's Oncologic Drugs Advisory Committee recommended accelerated approval for Ilex' Clolar (clofarabine) in the treatment of pediatric acute lymphoblastic leukemia, but not pediatric acute myelogenous leukemia, at its Dec. 1 meeting
Treatments described in literature constitute "available therapy" to treat relapsed, aggressive non-Hodgkin's lymphoma, cmte. says. Partial responses seen in the pivotal trial of the liposomal vincristine treatment are not reasonably likely to predict a clinical benefit, cmte. finds.