FDA grants Adcetris® Breakthrough Therapy Designation for frontline advanced Hodgkin Lymphoma

On 2^nd October 2017, Adcetris® (brentuximab vedotin [an antibody-drug conjugate directed against CD30]) in combination with chemotherapy was granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the frontline treatment of patients with advanced Classical Hodgkin Lymphoma (cHL).

The BTD was granted based on results from the phase III randomized ECHELON-1 (NCT01712490) study which is evaluating the combination of Adcetris® plus AVD doxorubicin [Adriamycin®], vinblastine, dacarbazine (A+AVD) compared to standard of care chemotherapy regimen (control arm) in patients with previously untreated advanced cHL. The primary endpoint of the study was Modified Progression Free Survival (mPFS) per Independent Review Facility (IRF).

Results from this phase III ECHELON-1 study showed that A+AVD significantly improved the mPFS compared to the control arm (HR = 0.770, P = 0.035). Full data of this study is to be presented at the  59^th American Society of Hematology (ASH) Meeting and Exposition, Atlanta, GA, USA, from 9^th–12^th December 2017.

A supplemental Biologics License Application (BLA) for Adcetris® in combination with chemotherapy for advanced cHL is expected to be submitted to the FDA before the end of 2017.