1. Eastman, Peggy

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The Oncologic Drugs Advisory Committee of the US Food and Drug Administration has scheduled a meeting for May 2 at its campus in White Oak, Maryland, at which committee members will discuss the new drug application (NDA) for tivozanib capsules for the treatment of advanced renal cell carcinoma. Tivozanib is an oral vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor that has been in clinical trials.

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Also discussed will be a drug/device combination product for injection for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.


ODAC, though, an independent committee that advises the FDA on oncology drugs, has been meeting at FDA less frequently in recent times because the NDAs have been better, said Richard Pazdur, MD, Director of FDA's Office of Oncology Drug Products. "I am very much more impressed by the quality of drugs and drug applications that are coming to us," he said at a recent meeting of the National Cancer Policy Forum of the Institute of Medicine. "You can see that by the drop in ODAC meetings; we don't need them."


Pazdur noted that in general new cancer drugs are more targeted and thus more specific to the cancer they are intended to treat-"We're moving away from those general cytotoxic drugs," he said.


Asked for his opinion for this article, ODAC Chair Mikkael Sekeres, MD, MS, Director of the Leukemia Program at the Cleveland Clinic Taussig Cancer Institute, said, "I can comment that there have been fewer ODAC meetings pertaining to specific drug applications over the last year, which implies that the FDA has not needed to seek external advice from our committee. This means that the FDA's risk/benefit analysis of a New Drug Application is more clear-cut, either in support of a drug's approval, or not."


Sekeres, OT's Clinical Advisory Editor for Hematology/Oncology, is also Chair of the Hematology/Oncology Pharmacy & Therapeutics Committee at his institution.


The FDA does not have to take the recommendations or advice of ODAC members, but often does.