FDA OKs Adcetris Label Expansion for Hodgkin’s Lymphoma

First FDA-approved regimen in frontline stage III or IV classical Hodgkin’s lymphoma in more than 40 years

The FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) in combination with chemotherapy in adult patients with previously untreated stage III or IV classical Hodgkin’s lymphoma. The approval is based on the successful outcome of the phase 3 ECHELON-1 clinical trial that compared brentuximab plus AVD (Adriamycin, vinblastine, and dacarbazine) with ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine). In addition, data from the ECHELON-1 trial converted the U.S. accelerated approval of brentuximab for the treatment of adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multiagent chemotherapy regimen to regular approval. In October 2017, the FDA granted breakthrough therapy designation to brentuximab in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin’s lymphoma. The FDA also granted priority review for the supplemental biologics license application, and the Prescription Drug User Fee Act target action date was May 1, 2018.

This is the fifth FDA-approved indication for brentuximab, which also has regular approval for adult patients with: 1) classical Hodgkin’s lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, 2) cHL after failure of auto-HSCT or failure of at least two prior multiagent chemotherapy regimens in patients who are not auto-HSCT candidates, 3) sALCL after failure of at least one prior multiagent chemotherapy regimen, and 4) primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy.

Source: Seattle Genetics; March 20, 2018.