The FDA granted the designation to brentuximab vedotin (Adcetris) for this indication in combination with cyclophosphamide, doxorubicin, and prednisone.
Officials with the FDA have granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressiong peripheral T-cell lymphomas (PTCLs) in combination with cyclophosphamide, doxorubicin, and prednisone (CHP), according to a press release.
Seattle Genetics previously submitted a supplemental Biologics License Application in November for this indication.
The designation is based on data from the phase 3 ECHELON-2 clinical trial evaluating the combination of brentuximab vedotin plus CHP as a frontline therapy compared with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in the control arm. The trial included 450 patients, approximately 75% of whom were to be diagnosed with sALCL.
According to the study data, patients treated with brentuximab vedotin plus CHP demonstrated a statistically significant improvement in progression-free survival (PFS) compared with CHOP as assessed by an Independent Review Facility (IRF; hazard ratio=0.71; p-value=0.0110). The study also showed superior overall survival, a key secondary endpoint, in patients treated with the combination compared with CHOP.
All other key secondary endpoints, including PFS in patients with sALCL, complete remission rate, and objective response rate were statistically significant in favor of the brentuximab vedotin plus CHP group, according to the study.
Additional data will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting.
Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on the surface of several types of PTCL, Seattle Genetics stated in the press release. The drug is also being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas, previously untreated Hodgkin lymphoma, cutaneous T-cell lymphoma, and relapsed/refractory Hodgkin lymphoma.
“This is the third Breakthrough Therapy Designation for ADCETRIS and supports our goal to make this therapy available to patients with newly diagnosed peripheral T-cell lymphomas as soon as possible,” Clay Siegall, PhD, president and chief executive officer of Seattle Genetics, said in a statement. “We look forward to presenting the data from our phase 3 ECHELON-2 trial at the upcoming ASH Annual Meeting.”
FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas [news release]. Seattle Genetics’ website. http://investor.seattlegenetics.com/news-releases/news-release-details/fda-grants-breakthrough-therapy-designation-adcetrisr. Accessed November 15, 2018.