Adcetris First FDA-Approved Drug for CD30-Expressing Peripheral T-Cell Lymphomas

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates


On November 16, 2018, the FDA approved brentuximab vedotin (Adcetris; Seattle Genetics), in combination with chemotherapy, for patients with untreated systemic ­anaplastic large-cell lymphoma (sALCL) or with other CD30-­expressing peripheral T-cell lymphomas (PTCLs), including angioim­munoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA-approved drug for newly diagnosed PTCL, including sALCL. Brentuximab vedotin was previously approved by the FDA for classical Hodg­kin lymphoma.

This new indication was based on a double-blind, multicenter clinical trial that randomized 226 patients to brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (CHP) and 226 patients to ­cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). The efficacy was demonstrated by improvement in progression-free survival (PFS). The median PFS was 48.2 months (95% confidence interval [CI], 35.2-not estimable) in the brentuximab vedotin plus CHP arm versus 20.8 months (95% CI, 12.7-47.6) in the brentuximab vedotin plus CHOP arm (hazard ratio [HR], 0.71; 95% CI, 0.54-0.93; P = .011). Improvements with brentuximab vedotin plus chemotherapy were also seen in overall survival (HR 0.66; 95% CI, 0.46-0.95; P = .024), complete response rates in the CHP and CHOP arms (68% vs 56%, respectively; P = .007), and overall response rates (83% vs 72%, respectively; P = .003).

The most common (≥20%) side effects that were more common in the brentuximab vedotin plus CHP arm were nausea, diarrhea, fatigue or asthenia, mucositis, pyrexia, vomiting, and anemia. Peripheral neuropathy was reported in 52% of patients in the CHP arm and 55% in the CHOP arm. The FDA used its new Real-Time Oncology Review Pilot Program to approve this indication, which took <2 weeks to complete.