Seattle Genetics announced that it has submitted a supplemental Biologics License Application (BLA) to the Food and Drug Administration (FDA) for Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma patients at high risk of relapse.
The sBLA submission was based on data from the Phase 3 AETHERA trial of Adcetris. The trial achieved its primary endpoint and demonstrated a significant increase in progression-free survival (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.
Adcetris is already indicated for the treatment of Hodgkin lymphoma 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.
For more information call (855) 473-2436 or visit SeattleGenetics.com.