FDA may hold approval of supplemental indications to a higher standard of evidence than what can feasibly be obtained since the drugs are already available to treat patients in an off-label setting, FDA Office of Drug Oncology Products Director Richard Pazdur indicated at a Sept. 1 advisory committee meeting.Pazdur told the Oncology Drugs Advisory Committee not to consider the need to have Genzyme's Clolar(clofarabine) available to treat elderly acute myeloid leukemia patients in voting whether or not a randomized trial should be required prior to the drug's approval for the new indication.
ODAC was convinced that clofarabine is active in getting elderly AML patients into remission, but ultimately voted 9-3 that the additional trial did need to be conducted prior to its approval - regardless of the enormous disease and patient population challenges that have stood in the way of conducting such trials thus far."This really is a level of evidence question that we're asking here," Pazdur said. "We're not asking 'can a randomized study be done,' 'would you like a randomized study to be done,' 'would it be nice if a randomized study were to be done.' The vote is: for a level of evidence for approval - cognizant that this does set precedence for other drugs - is a randomized study necessary in the proposed indication. Right now, availability is not an issue ... There are many ways of getting this drug [through] off-label use."
Hmm.
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