BLA Submitted for Brentuximab Vedotin for Hodgkin and Anaplastic Large Cell Lymphomas

Seattle Genetics announced that it has submitted a Biologics License Application (BLA) to the FDA for the use of brentuximab vedotin (SGN-35) to treat relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma. The BLA is based on results from both a pivotal trial in relapsed or refractory Hodgkin lymphoma and a Phase 2 trial in relapsed or refractory systemic ALCL. Results from the pivotal trial in 102 relapsed or refractory Hodgkin lymphoma patients demonstrated that: 94% of patients had reductions in tumor volume; 75% of patients achieved an objective response, including 34% with complete remission. Results from the Phase 2 trial in 58 relapsed or refractory systemic ALCL patients demonstrated that: 97% of patients had reductions in tumor volume; 86% of patients achieved an objective response, including 53% with complete remission.

Brentuximab vedotin is an antibody-drug conjugate (ADC) comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in a targeted cell-killing effect. 

For more information call (425) 527-4000 or visit www.seattlegenetics.com.