Brentuximab Vedotin (ADCETRIS®)
About Brentuximab Vedotin
Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to the CD30 antigen using Seattle Genetics' proprietary ADC technology. It comprises an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a cytotoxic (cell-killing) agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in target cell death.
We are developing brentuximab vedotin in collaboration with Millennium: The Takeda Oncology Company. Under the collaboration, Seattle Genetics has U.S. and Canadian commercialization rights and Millennium has commercialization rights in the rest of the world. The companies are funding joint worldwide development costs on a 50:50 basis, except in Japan where Millennium is fully responsible for development costs.
ADCETRIS® (brentuximab vedotin) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2011 and approval with conditions by Health Canada in February 2013 for relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma. Additionally, the European Commission granted Millennium conditional marketing authorization in October 2012.
We are also conducting a comprehensive clinical development program designed to evaluate brentuximab vedotin in earlier lines of Hodgkin lymphoma and systemic anaplastic large cell lymphoma, as well as in a broad array of other CD30-positive malignancies.
Three of our ongoing phase 3 clinical trials are being conducted under a Special Protocol Assessment (SPA) agreement from the FDA. They are:
- Phase III ECHELON-1 front-line Hodgkin lymphoma in combination with chemotherapy
- Phase III ECHELON-2 front-line CD30-positive mature T-cell lymphomas in combination with chemotherapy
- Phase III ALCANZA trial for relapsed CD30-positive cutaneous T-cell lymphoma
We have also worked closely with European regulators leading to scientific advice on our phase 3 trials.