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 Takeda Pharmaceutical Company. Under the collaboration, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda 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 Takeda is fully responsible for development costs.
ADCETRIS® (brentuximab vedotin) is approved for two indications in more than 55 countries, including the U.S., Canada, Japan and members of the European Union.
We are also conducting a comprehensive clinical development program in more than 30 corporate and investigator-sponsored clinical trials, including four phase 3 studies designed to evaluate the potential of brentuximab vedotin in earlier lines of its approved indications as well as in a many additional types of CD30-positive malignancies, including cutaneous T-cell lymphoma (CTCL), B-cell lymphomas and mature T-cell lymphomas (MTCL).
Based on positive results from the AETHERA phase 3 clinical trial, our supplemental Biologics License Application for ADCETRIS for the post-transplant consolidation treatment of Hodgkin lymphoma patients at high risk of relapse or progression is currently under review by the U.S. Food and Drug Administration.
These phase 3 clinical trials are currently enrolling participants:
- Phase 3 ECHELON-1 frontline Hodgkin lymphoma in combination with chemotherapy
- Phase 3 ECHELON-2 frontline CD30-positive mature T-cell lymphomas in combination with chemotherapy
- Phase 3 ALCANZA trial for relapsed CD30-positive cutaneous T-cell lymphoma