Brentuximab Vedotin Receives Breakthrough Therapy Designation for Frontline Hodgkin Lymphoma
The FDA has awarded brentuximab vedotin (Adcetris) on 02 October 2017 a breakthrough therapy designation for the first-line treatment of patients with classical Hodgkin lymphoma.
Brentuximab vedotin is an antibody-drug conjugate directed to CD30, a defining marker of the disease. The designation is based on phase III results from the ECHELON-1 clinical trial, which were released in June.
The 2-year rate of modified progression-free survival (PFS) for brentuximab vedotin plus AVD (adriamycin, vinblastine, dacarbazine) was 82.1% compared with 77.2% for patients receiving ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). The experimental combination reduced the risk of disease progression or death by 23% (HR, 0.770; P = .035). An interim analysis of 2-year overall survival (OS) also showed a trend favoring the brentuximab arm.
The 2-year rate of modified progression-free survival (PFS) for brentuximab vedotin plus AVD (adriamycin, vinblastine, dacarbazine) was 82.1% compared with 77.2% for patients receiving ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). The experimental combination reduced the risk of disease progression or death by 23% (HR, 0.770; P = .035). An interim analysis of 2-year overall survival (OS) also showed a trend favoring the brentuximab arm.
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