Adcetris(brentuximab vedotin)

Adcetris (brentuximab vedotin) is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. The recommended dose is 1.8 mg/kg administered every 3 weeks over 30 minutes.

In clinical trials, Adcetris demonstrated an overall objective response rate (ORR) of 75% and a complete response (CR) rate of 33%. The median duration of response was 6.7 months, and the median progression-free survival (PFS) was 5.6 months. For patients with prior ASCT, the overall CR rate for Adcetris was 34% compared to 15% for gemcitabine. In another study, the overall response rate (ORR) was 86% with a complete remission (CR) rate of 59%, and a median duration of response (DoR) of 13.2 months.

Safety data from 357 patients with CD30+ hematologic malignancies showed Grade 3 peripheral neuropathy in 14% of patients. One patient experienced fatal febrile neutropenia and septic shock. Adcetris received its initial U.S. approval in 2011 and its first marketing authorization in the EU in October 2012. It was granted orphan medicinal product designation on January 15, 2009.