Seattle Genetics announced that the FDA has accepted for filing two Biologics License Applications (BLAs) for brentuximab vedotin, including one for the treatment of patients with relapsed or refractory Hodgkin lymphoma and one for relapsed or refractory systemic anaplastic large cell lymphoma. The FDA has established a Prescription Drug User Fee Act action date of August 30, 2011.

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. 

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