Seattle Genetics Submits Supplemental BLA For Phase 3 AETHERA Trial Of ADCETRIS

By RTT News, February 18, 2015, 09:15:00 AM EDT

(RTTNews.com) - Seattle Genetics Inc. ( SGEN ) announced it has submitted a supplemental Biologics License Application (BLA) to the U.S. FDA based on data from the phase 3 AETHERA trial of ADCETRIS (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant in Hodgkin lymphoma patients at high risk of relapse. The trial achieved its primary endpoint and demonstrated a significant increase in progression-free survival (PFS) per independent review facility, with a hazard ratio of 0.57 and a p-value of 0.001.

Clay Siegall, CEO of Seattle Genetics, said: "Results from the AETHERA trial demonstrated that treating high risk Hodgkin lymphoma patients with ADCETRIS in following autologous stem cell transplant resulted in a statistically significant improvement in progression-free survival with a manageable safety profile. We believe that this is clinically meaningful and supports a label expansion for ADCETRIS in this setting."

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Seattle Genetics Submits Supplemental BLA For Phase 3 AETHERA Trial Of ADCETRIS