Adcetris Gets Breakthrough Therapy Designation for Frontline Peripheral T-Cell Lymphomas

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. Accessed November 15, 2018.

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Related Articles

Top news of the day from across the health care landscape.
Research could lead to the development of new cancer treatments to stop tumor growth.
Top news of the day from across the health care landscape.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.