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March 18, 2013
09:02 EDTSGENSeattle Genetics submits sBLA to FDA for ADCETRIS
Seattle Genetics has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration supporting the use of ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL. The sBLA is based on results from a phase II clinical trial with two treatment arms. One arm evaluated retreatment with ADCETRIS in patients who previously responded to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse. The other arm allowed treatment extension and evaluated prolonged treatment with ADCETRIS beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this phase II trial. Preliminary data from this trial were previously reported at the 2011 American Society of Hematology Annual Meeting and at the 2012 American Society of Clinical Oncology Annual meeting.
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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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