Puma Breaks A Long Losing Streak For Sponsors At ODAC
Puma is in select company after winning a strong vote from US FDA’s Oncologic Drugs Advisory Committee in favor of approval of its new cancer drug neratinib.
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It has been more than two years since a sponsor went before the Oncologic Drugs Advisory Committee and won a favorable vote on approval of a new drug application. Can FDA really expect an advisory committee to keep saying ‘no’ all the time?
US FDA’s top cancer drug reviewer has been uncharacteristically quiet during recent advisory committee meetings. That just changed, and the result may not have been great for the sponsor (Pfizer), but it is a reminder of the value that Pazdur’s institutional knowledge and outspokenness bring to all of FDA.
Conflict of interest waivers for US FDA advisory committee review of sunitinib's supplemental application signal that difference in statistical analyses for disease-free survival could be key area of discussion.