FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Seattle Genetics Wins Expanded Label for Lymphoma Drug

Nov. 17, 2017
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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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