FDA Approval Sought for Brentuximab Vedotin in CTCL

June 21, 2017 – A supplemental Biologics License Application (sBLA) has been submitted to the FDA for brentuximab vedotin as a treatment for patients with cutaneous T-cell lymphoma (CTCL), according to Seattle Genetics, which codevelops the antibody-drug conjugate with Takeda. The sBLA is primarily based on the phase III ALCANZA trial, in which brentuximab vedotin induced responses lasting at least 4 months in 56.3% of patients versus 12.5% in … (leggi tutto)