Adcetris, which is being jointly developed by Seattle Genetics and Takeda, is now approved for marketing of this indication in the 28 member states of the European Union, Norway, Liechtenstein and Iceland.
Adcetris is an ADC which features an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), using Seattle Genetics’ technology.
The approval was based on the phase III AETHERA trial, which demonstrated 75% enhancement in progression-free survival (PFS) for patients treated with Adcetris as consolidation therapy immediately following ASCT.
PFS was evaluated after a minimum of two years post initiation of treatment for all patients who participated in the trial. An updated analysis carried out after three years of follow up demonstrated sustained PFS improvement.
No statistically significant difference between the treatment arms were seen in a pre-specified interim analysis of overall survival.
Seattle Genetics president and CEO Clay Siegall said: "With the European Commission approval, Adcetris becomes the first and only consolidation treatment option available in both the United States and European Union for high risk classical Hodgkin lymphoma patients to preserve their remission post-transplant.
"This continues to support our goal to establish Adcetris as the global foundation of therapy for classical Hodgkin lymphoma and CD30-expressing lymphomas and provides a meaningful advance for cancer patients."