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Another Vote for Accelerated Approval

 
• By Michael McCaughan

The Oncologic Drugs Advisory Committee review of ApoPharma’s Ferriprox was not one of the highest profile meetings of the past year. But for sponsors concerned about the availability of the accelerated approval pathway, it was a very important event.

“This is a very particular situation, and one that I do not want to set as a precedent,” Office of Oncology & Hematology Products Director Richard Pazdur said shortly before the Oncologic Drugs Advisory Committee voted 10-2 in favor of approval of ApoPharma Inc. ’s iron chelation agent Ferriprox (deferiprone) for second line use in thalassemia patients during its September 14 meeting.

Pazdur’s concern is understandable, because this would be a heck of a precedent: Ferriprox is the first product granted accelerated approval based on a retrospective study. Add to that the...

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