New indication for Seattle Genetics' Adcetris approved by FDA

The US Food and Drug Administration has approved Seattle Genetics’ (Nasdaq: SGEN) Adcetris (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.

The news was released after markets closed on Monday, but Seattle Genetics’ stock was up more than 5% at $46.45 in post-market trading and a further 5.6% to $48.80 pre-market today.

The approval is based on a Phase III clinical trial called AETHERA that was designed to compare up to 16 cycles (around one year) of Adcetris therapy administered every three weeks following auto-HSCT to placebo. The primary endpoint was met with a significant improvement in median progression-free survival (PFS) of 42.9 months (95% CI: 30.4, 42.9) for patients who received Adcetris versus 24.1 months (95% CI: 11.5, not estimable) for patients who received placebo, an improvement of 18.8 months (hazard ratio=0.57 [95% CI: 0.40, 0.81]; p-value=0.001). In addition, data from the AETHERA trial converted the US accelerated approval of the relapsed classical HL indication to regular approval.