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FDA Approval Sought for Brentuximab Vedotin in Frontline CD30+ PTCL

Jason M. Broderick @jasoncology
Published: Monday, Nov 05, 2018

Clay Siegall, PhD

Clay Siegall, PhD
A supplemental biologics license application (sBLA) has been submitted to the FDA for the use of brentuximab vedotin (Adcetris) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

“Results from the ECHELON-2 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival and importantly, overall survival, in patients with previously untreated CD30-expressing PTCL who were treated with Adcetris in combination with CHP chemotherapy over standard of care CHOP chemotherapy. We believe these superior results over standard of care represent a significant advance for patients with CD30-expressing PTCL and for the medical community, and we look forward to working with the FDA during the review process of this application to bring this potential new treatment regimen to patients as quickly as possible,” added Siegall.

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