FDA Grants Breakthrough Therapy Designation to Brentuximab Vedotin for Hodgkin Lymphoma
The FDA granted Breakthrough Therapy Designation to brentuximab vedotin plus chemotherapy as first-line therapy for advanced classical Hodgkin lymphoma.
The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to brentuximab vedotin plus chemotherapy as first-line therapy for patients with advanced classical Hodgkin lymphoma.1
The FDA based its decision from topline results from the phase 3 ECHELON-1 study (ClinicalTrials.gov Identifier: NCT01712490), for which researchers randomly assigned 1334 patients with advanced Hodgkin lymphoma to receive adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) in the control arm, or brentuximab vedotin plus adriamycin, vinblastine, dacarbazine (AVD) in the experimental arm.
The 2-year modified progression-free survival (PFS) rate was 82.1% and 77.2% for the brentuximab vedotin plus AVD arm and ABVD arm, respectively, demonstrating that the brentuximab combination decreased the risk of disease progression and death (hazard ratio [HR], 0.770; P = .035).
Overall survival (OS), the secondary endpoint of the study, trended in favor of the brentuximab plus AVD arm.
The safety profile of brentuximab plus AVD was consistent with those previously reported for the individual components of the regimen and included adverse events such as nausea, vomiting, constipation, neutropenia, peripheral sensory neuropathy, and fatigue.
Brentuximab vedotin is being further evaluated for the treatment of various lymphomas in clinical studies, including ECHELON-2 (ClinicalTrials.gov Identifier: NCT01777152) and CheckMate 812 (ClinicalTrials.gov Identifier: NCT03138499).
The FDA grants breakthrough therapy designation to medications that treat serious conditions for which preliminary results demonstrate clinical benefit. Treatments address unmet medical needs and must have evidence for improvement on clinically significant endpoints over currently accepted therapeutic standards.
- Seattle Genetics receives FDA breakthrough therapy designation for ADCETRIS (brentuximab vedotin) in frontline advanced Hodgkin lymphoma [news release]. Bothell, WA: Seattle Genetics; October 2, 2017. http://investor.seagen.com/phoenix.zhtml?c=124860&p=irol-newsArticle&ID=2303867. Accessed October 2, 2017.