Seattle Genetics, Inc. announced that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the current conditional marketing authorization for Adcetris (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone).
Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of peripheral T-cell lymphomas (PTCL), including sALCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 27, 2020.“The approval of ADcetris in combination with CHP for use in the European Union for patients with previously untreated sALCL represents a significant advance for patients who previously were treated with CHOP chemotherapy regimen that was often unsuccessful in leading to long-term remissions,” said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “The outstanding results from the ECHELON-2 phase III trial, which demonstrated superior progression-free survival and overall survival compared to CHOP, led to this important regulatory milestone. We are pleased that our partner Takeda is able to make this clinically meaningful therapeutic option available to patients in Europe.”
The results from the ECHELON-2 phase III clinical trial were published in The Lancet in December 2018. The marketing authorization for Adcetris is valid in all countries of the European Union, Norway, Liechtenstein and Iceland.