FDA fast track designation granted for SGN-35 for Hodgkin lymphoma

Seattle Genetics announced that the FDA has granted fast track designation to SGN-35 for the treatment of Hodgkin lymphoma. SGN-35, an antibody-drug conjugate (ADC), is in an ongoing pivotal trial under a Special Protocol Assessment (SPA) from the FDA. The primary endpoint of the trial is objective response rate assessed by an independent radiographic facility. Secondary endpoints include duration of response, progression-free survival, overall survival and tolerability

SGN-35 is an 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.