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18 Jul 2011

FDA Panel Nods for Seattle Genetics Lymphoma Drug

The FDA advisory committee's votes followed what many industry watchers viewed as a mixed agency staff review of Seattle Genetics' application for approval of the drug for blood cancer.

An FDA panel of experts voted unanimously for accelerated approval of Seattle Genetics' drug brentuximab vedotin (Adcetris) for patients with aggressive forms related blood cancers called Hodgkin lymphoma and anaplastic large cell lymphoma.

 

The FDA advisory committee's votes followed what many industry watchers viewed as a mixed agency staff review of Seattle Genetics' application for approval of the drug for the two forms of blood cancer, in which questions were raised about whether the relatively small, single-arm trials that the company has completed to date show enough data of the drug's benefits. Yet those concerns didn't cause any of the advisory committee members to hold back from endorsing the drug's approval.

 

The FDA will take the recommendations fro

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