ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma has been granted breakthrough therapy designation by FDA.
ADCETRIS is an antibody drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma.
It is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate and investigator sponsored clinical trials. It is not approved as a frontline therapy for Hodgkin lymphoma.
ADCETRIS received breakthrough therapy designation 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). The safety profile of ADCETRIS+AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen.
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.