ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a marker of HL known to be expressed in some types of non-Hodgkin lymphoma, including ALCL. The approval was based on two global Phase II trials of ADCETRIS for patients with relapsed or refractory CD30-positive HL and ALCL. In March 2012 ADCETRIS was granted orphan drug designation by Japanese MHLW for the treatment of patients with HL and ALCL.
“Until now, patients in Japan with relapsed or refractory Hodgkin lymphoma or ALCL had few therapeutic treatment options, and the approval of ADCETRIS represents a significant milestone in making this innovative targeted therapy available to these patients in need,” said Clay B. Siegall, Ph.D., president and chief executive officer of Seattle Genetics. “ADCETRIS is now approved in 39 countries, and we continue to work with our collaborator, Takeda, to expand regulatory approvals globally. Through both our regulatory activities and robust clinical development program, our goal is to establish ADCETRIS as the foundation of therapy worldwide for patients with CD30-positive malignancies.”