Seattle Genetics Seeks to Market Adcetris as Consolidation Therapy in ASCTs

Seattle Genetics announced that it has submitted a supplemental Biologics License Application (sBLA) to the Food and Drug Administration (FDA) for Adcetris (brentuximab vedotin). The drug will be used as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin's lymphoma patients who are considered to be at high risk of relapse.

The company submitted the sBLA based on data from its Phase III AETHERA trial of Adcetris. This trial achieved its primary endpoint and demonstrated a significant increase in progression-free survival (PFS). Median PFS was 43 months for patients who received Adcetris in comparison to 24 months for patients who received a placebo. The two year PFS rate was 63 percent in the Adcetris arm compared to 51 percnt in the placebo arm.

Consistent benefit in testing leads to approval for consolidation therapy

This PFS benefit was consistent across all pre-specified subgroups, including:

1. Primary refractory patients.
2. Patients who relapsed within twelve months of frontline therapy.
3. Patients who relapsed after twelve months with extranodal disease.

Adcetris is currently approved for the treatment of Hodgkin's 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.

To learn more about consolidation therapy, click here.

Source: Seattle Genetics