Health Canada approves Adcetris + chemotherapy in frontline CD30-expressing peripheral T-cell lymphoma .- Seattle Genetics

Seattle Genetics, Inc. announced that Health Canada has approved the supplemental New Drug Submission that expands the use of Adcetris (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) chemotherapy for the treatment of previously untreated adult patients with systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumours express CD30.

The approval is based on positive results of the phase III ECHELON-2 clinical trial that compared Adcetris plus CHP to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). Health Canada granted a Priority Review Designation for this submission. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL.

�The Health Canada approval of Adcetris (brentuximab vedotin) in combination with CHP chemotherapy in newly diagnosed CD30-expressing peripheral T-cell lymphoma represents the first major advance for Canadian patients with PTCL in decades,� said Kerry Savage, M.D., Medical Oncologist at the BC Cancer Agency, Professor of Medicine at the University of British Columbia and investigator on the ECHELON-2 clinical trial. �The approval is based on the ECHELON-2 clinical trial that demonstrated Adcetris (brentuximab vedotin) plus CHP regimen was superior for both progression-free survival and all key secondary endpoints, including overall survival, when compared to the standard of care CHOP chemotherapy.�