FDA accepts for filing a supplemental Biologics License Application based on data from the phase III ALCANZA trial and two phase II trials of Adcetris (brentuximab vedotin) for cutaneous T-cell lymphoma (CTCL).- Seattle Genetics + Takeda Oncology

Seattle Genetics, Inc. announced that the FDA has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase III ALCANZA trial and two phase II investigator-sponsored trials of ADcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL). In November 2016, the FDA granted Adcetris Breakthrough Therapy Designation (BTD) for the treatment of patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma who require systemic therapy and have received one prior systemic therapy. These represent the most common subtypes of CTCL.

The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is 16 December 2017. Adcetris is currently not approved for the treatment of CTCL.