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 Cell Transplantation Consolidation
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- 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 Following Autologous Hematopoietic Transplantation in Classical Hodgkin Lymphoma
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Seattle Genetics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. The approval is based on a phase 3 clinical trial called AETHERA that was designed to compare up to 16 cycles (approximately one year) of ADCETRIS therapy administered every three weeks following auto-HSCT to placebo
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