FDA's Pazdur urges Seattle Genetics to connect quickly with agency post-positive ODAC
This article was originally published in Scrip
The head of the US FDA's oncology office made no bones about it on 14 July that Seattle Genetics already had the accelerated approval of the firm's CD30-directed antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in the bag, even though regulators have yet to bestow their final decree, which is expected to come by the end of next month. But Dr Richard Pazdur, director of the FDA's Office of Oncology Drug Products, also made it clear that it is time to stop pussyfooting around and nail down an agreement on confirmatory trials.
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