20 March 2018 - The U.S. FDA today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.

The approval for adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) was based on a clinical trial comparing Adcetris plus chemotherapy (Adriamycin [doxorubicin], vinblastine and dacarbazine, or AVD) to a chemotherapy-only regimen common for cHL treatment (AVD plus bleomycin, also known as ABVD). The trial measured modified progression-free survival (mPFS), which considers the length of time it took for the disease to progress, death to occur, or new therapy to be initiated in patients who did not achieve a complete response. In the trial of 1,334 patients, after patients received an average of six 28-day cycles of treatment, those treated with Adcetris plus AVD were 23% less likely to experience progression, death, or initiation of new therapy compared with those receiving ABVD. There were 117 (18%) patients on the Adcetris plus AVD arm who experienced disease progression, death, or began new therapy compared to 146 (22%) patients on the ABVD arm.

The FDA granted this application priority review and breakthrough therapy designations. 

Read FDA press release