August 18, 2015
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FDA approves Adcetris for high-risk patients with classical Hodgkin's lymphoma

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The FDA approved brentuximab vedotin as post-autologous hematopoietic stem cell transplantation consolidation for patients with classical Hodgkin’s lymphoma who are at a high risk for relapse or progression, according to a press release from the drug’s manufacturer.

The FDA based its decision in part on results of the phase 3 ATHERA trial — published in March in The Lancet and presented at the American Society of Hematology Annual Meeting and Exposition in December 2014 —  designed to compare brentuximab vedotin (Adcetris, Seattle Genetics) vs. placebo following autologous hematopoietic stem cell transplantation. The analysis included 329 patients with Hodgkin’s lymphoma who were at risk for relapse or progression, 165 of whom received up to 16 cycles of brentuximab vedotin every 3 weeks. The other 164 patients received placebo.

The trial met its primary endpoint with a median PFS improvement of 18.8 months (HR = 0.57; 95% CI, 0.4-0.81). Patients assigned brentuximab vedotin achieved a median PFS of 42.9 months (95% CI, 30.4-42.9), whereas patients assigned placebo achieved a median PFS of 24.1 months (95% CI, 11.5 to not estimable).

In August 2011, the FDA granted accelerated approval to brentuximab vedotin for the treatment of patients with Hodgkin’s lymphoma who failed autologous transplant or who failed at least two prior multi-agent chemotherapy regimens and who are not autologous transplant candidates.

Craig Moskowitz, MD

Craig Moskowitz

The FDA also approved the agent for patients with systemic anaplastic large cell lymphoma who failed at least one prior multi-agent chemotherapy regimen.

“The FDA approval of brentuximab vedotin for post-autologous hematopoietic transplantation consolidation treatment in classical Hodgkin’s lymphoma patients with high risk of relapse or progression is a significant milestone for patients and physicians,” Craig Moskowitz, MD, lead investigator on the ATHERA trial, clinical director of the division of hematologic oncology at Memorial Sloan Kettering Cancer Center and a HemOnc Today Editorial Board member, said in a press release. “Approximately half of all Hodgkin’s lymphoma patients who undergo an autologous hematopoietic stem cell transplant will relapse, representing a significant need for additional treatment options to improve PFS.”