Pharma Focus Asia

Breakthrough Therapy Designation to Adcetris for Frontline Advanced Hodgkin Lymphoma

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.

magazine-slider-imageCytiva - Supor Prime filtersMFA + MMA 2024CPHI China || PMEC China 2024Asia Healthcare Week 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Advanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference3rd World ADC Asia 2024LogiPharma Asia 2024