FDA grants breakthrough status to new Hodgkin's lymphoma therapy
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin's lymphoma.
Jointly developed by Seattle Genetics and Takeda, adcetris an antibody-drug conjugate (ADC) directed to CD30. It is designed to employ a linker system that releases monomethyl auristatin E (MMAE) upon internalisation into CD30-positive tumour cells.
Seattle Genetics president and chief executive officer Clay Siegall said: "The decision by the FDA to grant this designation recognises the need for new options that can change the care of people with newly diagnosed advanced Hodgkin's lymphoma.
“The designation supports our goal to make adcetris available to patients in this setting as soon as possible.”
The designation was granted based on data from the Phase III Echelon-1 study, which is a randomised, open-label clinical trial that investigated adcetris plus AVD versus ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine).
The multi-centre trial enrolled 1,334 patients and was conducted in North America, Europe, South America, Australia, Asia and Africa.
Siegall added: “The Phase III Echelon-1 study that supports the Breakthrough Therapy Designation for adcetris in combination with chemotherapy showed superior activity versus the standard of care chemotherapy regimen in the treatment of frontline advanced classical Hodgkin lymphoma patients.
"We look forward to presenting the data from our Phase III Echelon-1 trial at the upcoming ASH annual meeting and intend to submit a supplemental Biologics License Application to the FDA before the end of 2017."
Adcetris is being evaluated in more than 70 clinical trials, including four Phase III studies: the Echelon-1 trial, the ongoing Echelon-2 trial in frontline mature T-cell lymphomas, the completed Alcanza trial in cutaneous T-cell lymphoma and the recently initiated Checkmate 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.
The drug has received marketing authorisation in 67 countries for relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL).
Adcetris is currently not approved as a frontline therapy for Hodgkin's lymphoma.