Breakthrough Therapy Designation to Adcetris for Frontline Advanced Hodgkin Lymphoma
The FDA has granted breakthrough therapy designation to ADCETRIS (Brentuximab Vedotin) in combination with chemotherapy as a frontline treatment for advanced classical Hodgkin lymphoma. ADCETRIS is an antibody drug conjugate (ADC) that targets CD30, a key marker of this type of lymphoma.
Although ADCETRIS is not currently approved as a frontline therapy for Hodgkin lymphoma, it is being evaluated globally in over 70 corporate and investigator-sponsored clinical trials as a foundational treatment for CD30-expressing lymphomas. The breakthrough therapy designation recognizes the potential of ADCETRIS in this setting.
The designation was based on data from the phase III ECHELON-1 study (NCT01712490), which compared the combination of ADCETRIS plus AVD (Adriamycin, vinblastine, dacarbazine) to the standard chemotherapy regimen (control arm) in previously untreated advanced classical Hodgkin lymphoma patients.
The study's primary endpoint was Modified Progression-Free Survival (mPFS) assessed by an Independent Review Facility (IRF). Results from the ECHELON-1 study showed that ADCETRIS plus AVD significantly improved mPFS compared to the control arm (HR = 0.770, P = 0.035). The safety profile of ADCETRIS plus AVD was consistent with the individual components of the regimen.
A supplemental Biologics License Application (BLA) for ADCETRIS in combination with chemotherapy for advanced classical Hodgkin lymphoma is expected to be submitted to the FDA by the end of 2017.
