Leerink Partners Remain Bullish on Seattle Genetics (SGEN) Following FDA's Approval of Adcetris

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Go back to Leerink Partners Remain Bullish on Seattle Genetics (SGEN) Following FDA's Approval of Adcetris

Seattle Genetics Announces FDA Regular Approval of ADCETRIS® (Brentuximab Vedotin) for Classical Hodgkin Lymphoma Patients at High Risk of Relapse or Progression as Post-Autologous Hematopoietic Stem

August 17, 2015 4:08 PM EDT

-FDA Approval Based on the Phase 3 AETHERA Clinical Trial Results-

-AETHERA Trial Also Converts Prior Accelerated Approval to Regular Approval in Treatment of Classical Hodgkin Lymphoma Patients who Fail Autologous Hematopoietic Transplantation or who Fail at Least Two Prior Multi-Agent Chemotherapy Regimens and are Not Autologous Hematopoietic Transplantation Candidates-

-Label Expansion Represents Third Indication for ADCETRIS in the U.S. and the First of Four Phase 3 Clinical Trials Intended to Broaden the Global Use of ADCETRIS in CD30-Expressing Lymphomas-

-ADCETRIS is the Only FDA-Approved Therapy to Prolong Progression-Free Survival... More