Seattle Genetics announced that the Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) in combination with chemotherapy in adults with previously untreated Stage III or IV classical Hodgkin lymphoma. Also, the accelerated approval of Adcetris for adults with systemic anaplastic large cell lymphoma (AsALCL) after failure of ≥1 multi-agent chemotherapy regimen has been converted to regular approval.

The expanded approval was supported by data from the Phase 3 ECHELON-1 clinical trial (N=1,334) which evaluated Adcetris + AVD (adriamycin, vinblastine, dacarbazine) vs ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). The trial met its primary endpoint with Adcetris + AVD resulting in a statistically significant improvement in modified progression-free survival (PFS) vs ABVD control (hazard ratio [HR] 0.77, 95% CI: 0.60-0.98; P=0.035), corresponding to a 23% reduction in the risk of progression, death or need for additional anticancer therapy in patients without complete response (CR) after frontline treatment. 

Overall survival (OS), a key secondary endpoint, favored Adcetris + AVD in an interim analysis but the difference was not significant (HR 0.72, 95 %CI: 0.44-1.17; P=0.19). The CR rate was 73% in the Adcetris + AVD arm vs 70% in the ABVD arm. 

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Adcetris, a CD30-directed antibody-drug conjugate, is already indicated to treat:

  • classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, 
  • cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
  • sALCL after failure of at least one prior multi-agent chemotherapy regimen
  • primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy

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