FDA Grants Brentuximab Vedotin Priority Review for CTCL

August 16, 2017 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for brentuximab vedotin for the treatment of 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 … (leggi tutto)