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FDA accepts Seattle Genetics marketing application for Adcetris for CTCL, action date December 16; shares ahead 1%

Published 08/16/2017, 10:38 AM
© Reuters.  FDA accepts Seattle Genetics marketing application for Adcetris for CTCL, action date December 16; shares ahead 1%
SGEN
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  • The FDA accepts for review Seattle Genetics' (SGEN +1.1%) supplemental Biologics License Application (sBLA) seeking approval to use ADCETRIS (brentuximab vedotin) to treat patients with cutaneous T-cell lymphoma (CTCL). The agency's action date is December 16, a Saturday, so expect an earlier decision.
  • ADCETRIS is currently approved in the U.S. to treat certain patients with classical Hodgkin lymphoma and anaplastic large cell lymphoma.
  • Now read: FDA accepts Portola's AndexXa marketing application, action date February 2, 2018


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