FDA Approval Summary: Brentuximab Vedotin in First‐Line Treatment of Peripheral T‐Cell Lymphoma. (26th March 2019)

• Record Type: Journal Article
• Authors: Richardson, Nicholas C.; Kasamon, Yvette L.; Chen, Haiyan; de Claro, R. Angelo; Ye, Jingjing; Blumenthal, Gideon M.; Farrell, Ann T.; Pazdur, Richard
• Is Part Of: Oncologist. Volume 24:Number 5(2019)
• Page Start: e180
• Page End: e187
• Publication Date: 2019-03-26
• Subjects: Adcetris -- Anaplastic large cell lymphoma -- Brentuximab vedotin -- CD30 antigen -- Peripheral T‐cell lymphoma; Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1634/theoncologist.2019-0098
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract: : In November 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (BV) for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma or other CD30‐expressing peripheral T‐cell lymphomas (PTCL), including angioimmunoblastic T‐cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP). Approval was based on ECHELON‐2, a randomized, double‐blind, actively controlled trial that compared BV+CHP with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in 452 patients with newly diagnosed, CD30‐expressing PTCL. Efficacy was based on independent review facility‐assessed progression‐free survival (PFS). The median PFS was 48.2 months with BV+CHP versus 20.8 months with CHOP, resulting in a hazard ratio (HR) of 0.71 (95% confidence interval [CI]: 0.54–0.93). The trial also demonstrated improvement in overall survival (HR 0.66; 95% CI: 0.46–0.95), complete response rate (68% vs. 56%), and overall response rate (83% vs. 72%) with BV+CHP. The most common adverse reactions (incidence ≥20%) observed ≥2% more with BV+CHP were nausea, diarrhea, fatigue or asthenia, mucositis, pyrexia, vomiting, and anemia. Peripheral neuropathy rates were similar (52% with BV+CHP, 55% with CHOP). Through the Real‐Time Oncology Review pilot program, which allows FDA early access to key data, FDA granted this approval less than 2 weeks after official submission of the application. Abstract : This article summarizes the clinical review and basis of approval of brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone as a first‐line regimen for patients with CD30‐expressing peripheral T‐cell lymphoma.