- Seattle Genetics (SGEN +2.4%) submits a supplemental Biologics License Application (sBLA) to the FDA for the use of Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma (HL) patients at high risk of relapse.
- Adcetris is currently cleared for the treatment of HL after failure of autologous stem cell transplant or, for HL patients who are not candidates for ASCT, after failure of at least two multi-agent chemotherapy regimens and systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemo regimen.
- President & CEO Clay B. Siegall, Ph.D., says, "With approximately half of all Hodgkin lymphoma patients who undergo an autologous stem cell transplant experiencing disease relapse, there is a significant need to identify regimens that extend progression-free survival (PFS). Results from the AETHERA trial demonstrated that treating high risk Hodgkin lymphoma patients with Adcetris following [ASCT] resulted in a statistically significant improvement in PFS with a manageable safety profile. We believe that this is clinically meaningful and supports a label expansion for Adcetris in this setting."
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)