FDA Approves Brentuximab Vedotin for Frontline Treatment of Classical Hodgkin Lymphoma

The FDA has approved brentuximab vedotin (Adcentris) in combination with chemotherapy for adults with previously untreated state 3 or 4 classical Hodgkin lymphoma based on results of the ECHELON-1 study.

Brentuximab vedotin (Adcetris) in combination with chemotherapy has gained FDA approval for the treatment of adult patients with previously untreated stage 3 or 4 classical Hodgkin lymphoma, according to a press release from Seattle Genetics. This marks the first FDA-approved regimen in frontline treatment of stage 3 or 4 classical Hodgkin lymphoma in more than 40 years.

“The standard of care for treating newly diagnosed advanced Hodgkin lymphoma has not changed in more than 4 decades,” said Joseph M. Connors, MD, FRCPC, clinical director, Center for Lymphoid Cancer, BC Cancer in Vancouver, Canada, in a statement. “For years, the physician community has been conducting clinical trials to identify improved regimens that are both less toxic and more effective to no vail.”

The approval follows successful results from the phase 3 ECHELON-1 clinical trial, which compared brentuximab vedotin plus Adriamycin, vinblastine, and dacarbazine (AVD) to Adriamycin, bleomycin, vinblastine and dacarbazine (ABVD). Results of the trial showed that the combination of brentuximab vedotin in combination with AVD yielded significantly improved progression-free survival, corresponding to a 23% reduction in risk of progression, death, or need for additional treatment.

Data from the trial also resulted in the US accelerated approval of brentuximab vedotin for the treatment of adults with systemic anaplastic large cell lymphoma after failure of at least 1 multi-agent chemotherapy regimen being converted to regular approval.

This is the fifth FDA-approved indication for brentuximab vedotin, which also has indications for adult patients with:

  • Classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation consolidation
  • Classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation or failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not autologous hematopoietic stem cell transplantation candidates
  • Systemic anaplastic large cell lymphoma after failure of at least 1 prior multi-agent chemotherapy regimen
  • Primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systematic therapy