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February 12, 2014
07:12 EDTSGENSeattle Genetics 2014 Adcetris guidance good, says RBC Capital
RBC Capital noted that Seattle Genetics' guidance for 2014 Adcetris sales was in-line with RBC Capital's estimate but below the consensus outlook. RBC Capital thinks the consensus outlook was flawed as it failed to take into account the lack of major catalysts for the drug until possibly late 2014. RBC Capital keeps an Outperform rating on Seattle Genetics.
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February 18, 2015
09:05 EDTSGENSeattle Genetics submits supplemental BLA to FDA for Phase 3 Aethera trial
Seattle Genetics announced that it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration based on data from the phase 3 AETHERA trial of ADCETRIS as consolidation therapy immediately following an autologous stem cell transplant in Hodgkin lymphoma patients at high risk of relapse. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma. ADCETRIS is approved in relapsed HL and sALCL but is currently not approved for consolidation therapy in HL patients immediately after ASCT. The supplemental BLA is based on positive results from a phase 3 clinical trial called AETHERA that were presented at the 56th American Society of Hematology Annual Meeting in December 2014. Results from the AETHERA trial in 329 HL patients at high risk of relapse included: The trial achieved its primary endpoint and demonstrated a significant increase in progression-free survival per independent review facility, with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate was 63 percent in the ADCETRIS arm compared to 51 percent in the placebo arm. The PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease.

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