Adcetris Earns Indication for Post Transplant Consolidation

Seattle Genetics has announced that the US Food and Drug Administration (FDA) has expanded the indications for their Hodgkin's lymphoma treatment Adcetris (brentuximab vedotin).

Previously, the FDA had approved Adcetris for two indications: for the treatment of classical Hodgkin lymphoma after failure of auto-hematopoietic stem cell transplantation (HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, and systemic anaplastic large cell lymphoma (sALCL) in patients who have failed at least one prior multi-agent chemotherapy regimen.

Now, Adcetris has been approved as consolidation therapy.

Specifically, back in February Seattle Genetics submitted a supplemental Biologics License Application (sBLA) to the FDA for Adcetris seeking approval for the treatment to 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 or disease progression.

This makes Adcetris the first and the only consolidation therapy approved for these patients.

Source: Seattle Genetics