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Puma Breaks A Long Losing Streak For Sponsors At ODAC

Executive Summary

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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The Return of The Pazdur Moment

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.

Pfizer Sutent Label Expansion May Hinge On Disease-Free Survival Stats

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.

Unmet Need Can Trump Anything At US FDA Panels, Even An Ill-Prepared Sponsor

Emmaus was unable to answer several questions about its product and was also missing several pieces of data, but FDA's Oncologic Drugs Advisory Committee didn't criticize the sponsor, and instead praised it for paying attention to the largely neglected sickle cell disease.

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