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Pharmaceuticals / Submissions and Approvals

Seattle Genetics Wins Expanded Label for Lymphoma Drug

Nov. 17, 2017

FDA expanded the label of Seattle Genetics’ Adcetris (brentuximab vedotin), approving its use in treating primary cutaneous anaplastic large-cell lymphoma and CD30-expressing mycosis fungoides, a common form of the disease.

The agency approved the expanded indication for the cancer drug a month before its Dec. 16 action date.

Adcetris was previously approved for relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma. The approval derived from positive data from a Phase III trial as well as two Phase II trials.

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