FDA approves Seattle Genetics' Adcetris

FDA granted accelerated approval to Adcetris brentuximab vedotin from Seattle Genetics Inc. (NASDAQ:SGEN) to treat Hodgkin's lymphoma and anaplastic large cell lymphoma. FDA, which approved Adcetris ahead of its Aug. 30 PDUFA date, said the drug is the first new approved treatment for Hodgkin's lymphoma since 1977 and the first specifically indicated for ALCL. Seattle Genetics said it will launch the product next week. Seattle Genetics gained $1.09 to $15.04 on Friday.

Seattle Genetics is required to conduct two new Phase III trials, one for each indication, according to a letter from FDA. The company had hoped to use the ongoing Phase III AETHERA trial of Adcetris in Hodgkin's lymphoma as a confirmatory trial. ...