Posted by Michael Wonder on 18 Nov 2016
Seattle Genetics receives FDA breakthrough therapy designation for Adcentis (brentuximab vedotin) in mycosis fungoides and primary cutaneous anaplastic large cell lymphoma
10 November 2016 - Submission of supplemental biologics license application for Adcetris in CD30-expressing CTCL planned in first half of 2017.
Seattle Genetics today announced that the U.S. FDA has granted breakthrough therapy designation to Adcetris (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy.
MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75 percent of the disease. Adcetris has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA study.
