Adcetris sBLA gets Priority Review for CTCL

Seattle Genetics Inc. (NASDAQ:SGEN) said FDA accepted and granted Priority Review to an sBLA for Adcetris brentuximab vedotin (SGN-35) to treat cutaneous T cell lymphoma (CTCL) patients requiring systemic therapy. Its PDUFA date is Dec. 16.

The sBLA is based on data from the Phase III ALCANZA trial in patients who received prior systemic or radiation therapy, in which 56.3% of patients receiving Adcetris had an objective response lasting at least 4 months vs. 12.5% of patients receiving investigator's choice of therapy (p<0.0001) (see BioCentury, Aug. 8, 2016)...