Seattle Genetics Nabs FDA Breakthrough Therapy Designation for Adcetris

Seattle Genetics has been granted FDA breakthrough therapy designation for its lymphoma therapy, Adcetris.

The decision was based on data from the Phase III Alcanza clinical trial. The Phase III Alcanza trial evaluated Adcetris in CD30-expressing cutaneous T-cell lymphoma (CTCL) and met its primary endpoint.

Adcetris is an antibody-drug conjugate directed to CD30 which is expressed on skin lesions in approximately 50 percent of patients with CTCL.  Adcetris is currently not approved for the treatment of CTCL.