FDA Grants Regular Approval to Brentuximab Vedotin in High-Risk Classical Hodgkin Lymphoma


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The U.S. Food and Drug Administration has approved brentuximab vedotin (Adcetris) as post–autologous hematopoietic stem cell transplantation consolidation treatment for patients with classical Hodgkin lymphoma at high risk of relapse or progression, Seattle Genetics has announced.

The approval is based on the phase III AETHERA trial that was designed to compare up to 16 cycles (approximately 1 year) of brentuximab vedotin therapy administered every 3 weeks following autologous hematopoietic stem cell transplantation to placebo. The primary endpoint was met with a significant improvement in median progression-free survival of 42.9 months (95% confidence interval [CI] = 30.4–42.9) for patients who received brentuximab vedotin vs 24.1 months (95% CI = 11.5–not estimable) for patients who received placebo, an improvement of 18.8 months (hazard ratio [HR] = 0.57; 95% CI = 0.40–0.81, P = .001).

In addition, data from the AETHERA trial converted the U.S. accelerated approval of the relapsed classical Hodgkin lymphoma indication to regular approval.

Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed in classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma, as well as other lymphoma subtypes. This is the third indication for brentuximab vedotin, which was granted accelerated FDA approval in August 2011 for two other indications: (1) treatment of Hodgkin lymphoma patients for whom autologous transplant or at least two prior multiagent chemotherapy regimens have failed, and who are not autologous transplant candidates; and (2) treatment of systemic anaplastic large cell lymphoma patients for whom at least one one prior multiagent chemotherapy regimen has failed. ■



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