The Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin; Seattle Genetics) for the treatment of adult patients with previously untreated anaplastic large cell lymphoma (sALCL) 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). 

The approval was based on data from a randomized, double-blind, double-dummy, actively controlled trial (ECHELON-2) involving 452 patients with certain PTCLs. Patients received either Adcetris plus chemotherapy (Adcetris 1.8mg/kg over 30 minutes, cyclophosphamide 750mg/m2, doxorubicin 50mg/m2, and prednisone 100mg orally) or a standard chemotherapy (CHOP; cyclophosphamide 750mg/m2, doxorubicin 50mg/m2, vincristine 1.4mg/m2, and prednisone 100mg orally) as first-line treatment. The primary efficacy measure was progression-free survival (PFS), defined as time from randomization to progression, death due to any case, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease; other endpoints included overall survival, complete response rate and overall response rate.

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Results showed PFS was significantly longer (hazard ratio [HR] 0.71 (95% CI, 0.54, 0.93; P =.011) in the Adcetris arm (median 48.2 months vs 20.8 months with CHOP). Overall survival (HR 0.66 [95% CI, 0.46, 0.95; P =.024]) and overall response rates (83% vs 72% with CHOP; P =.003) were also significantly better in the Adcetris arm.

“The current standard of care for initial treatment of peripheral T-cell lymphoma is multi-agent chemotherapy. That treatment has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments,” said Steven Horwitz, MD, Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York. “The ECHELON-2 clinical trial demonstrated Adcetris plus CHP was superior to the current standard of care, CHOP, for both progression-free survival and all other key secondary endpoints, including, most importantly, overall survival.”

This first-line treatment was approved using a new review program, the Real-Time Oncology Review program, which allows the FDA to access key data before the official application submission.

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