FDA Agrees to Review Adcetris for Post-Transplant Consolidation Therapy

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Seattle Genetics announced that the Food and Drug Administration (FDA) has accepted for filing the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression./ F7 K' A' D) Z1 n* M
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The sBLA submission is based on positive results from a Phase 3 AETHERA trial that was designed to determine if 16 cycles of Adcetris as consolidation therapy immediately following an autologous stem cell transplant (ASCT) could extend progression-free survival (PFS) in HL patients at high risk of relapse or progression. The trial achieved its primary endpoint and demonstrated a significant increase in PFS, with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS was 43 months for patients who received Adcetris vs. 24 months for patients who received placebo. The two-year PFS rate was 63% in the Adcetris arm compared to 51% 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.' b7 Q9 p% n3 e
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RELATED: Adcetris sBLA Submitted for Post-Transplant Hodgkin Lymphoma
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. Q. h: t1 Q; }/ u4 Z1 w( ^( X1 Z6 ]- ]Adcetris is an antibody-drug conjugate (ADC) already indicated for the treatment of HL after failure of ASCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. It is also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.