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FDA expands approval of Adcetris for advanced classical Hodgkin Lymphoma
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The FDA expanded the approval of brentuximab vedotin in combination with chemotherapy for the frontline treatment of adults with stage III or stage IV classical Hodgkin lymphoma, according to the agent’s manufacturer.
Brentuximab vedotin (Adcetris, Seattle Genetics) is indicated for the treatment of certain patients with classical Hodgkin lymphoma following autologous hematopoietic stem cell transplantation and certain patients with systemic anaplastic large cell lymphoma.
The FDA based this approval on the phase 3 ECHELON-1 trial of 1,334 patients treated with brentuximab vedotin plus AVD (adriamycin, vinblastine and dacarbazine) or ABVD (adriamycin, bleomycin, vinblastine and dacarbazine).
As HemOnc Today previously reported, researchers presented results at the ASH Annual Meeting and Exposition.
Results showed brentuximab vedotin plus AVD chemotherapy significantly improved PFS (HR = 0.77; 95% CI, 0.6-0.98). At an interim OS analysis, brentuximab vedotin appeared associated with superior OS (HR = 0.72; 95% CI, 0.44-1.17) compared with the control arm; however, the improvement did not reach statistical significance.
The complete response rate was 73% in the brentuximab vedotin arm compared with 70% in the control arm.
The safety profile of brentuximab vedotin combination appeared generally consistent with the known profiles for the single agents. The most common adverse events — occurring in more than 10% of patients — included anemia, neutropenia, peripheral sensory neuropathy, constipation, vomiting, diarrhea, pyrexia, decreased weight, stomatitis, abdominal pain, febrile neutropenia, bone pain, insomnia, decreased appetite, back pain, rashes/eruptions/exanthemas, dyspnea, peripheral motor neuropathy and increased alanine aminotransferase. The most common grade 3 or grade 4 events included neutropenia, febrile neutropenia and anemia.
“The standard of care for treating newly diagnosed advanced Hodgkin lymphoma has not changed in more than 4 decades. For years, the physician community has been conducting clinical trials to identify improved regimens that are both less toxic and more effective to no avail,” Joseph M. Connors, MD, FRCPC, clinical director of the Center for Lymphoid Cancer at BC Cancer in Vancouver, said in a company-issued press release. “The ECHELON-1 study results demonstrated superior efficacy of the Adcetris-plus-chemotherapy regimen when compared [with] the standard of care while removing bleomycin, an agent that can cause unpredictable and sometimes fatal lung toxicity, completely from the regimen. This represents a meaningful advance for this often younger patient population.”
Data from the ECHELON-1 trial also converted the FDA’s accelerated approval of brentuximab vedotin for the treatment of adults with systemic anaplastic large cell lymphoma after failure of at least one multiagent chemotherapy regimen to regular approval.