FDA accepts Seattle Genetics Adcetris application
BOTHELL, Wash. (AP) — Drug developer Seattle Genetics Inc. said Tuesday the Food and Drug Administration has accepted its application to market the lymphatic cancer treatment Adcetris for some additional uses.
The Bothell, Wash., company is seeking approval for Adcetris to be used in treating patients who had previously taken the drug, stopped and then saw their disease progress or relapse. It also wants approval for Adcetris to be used in treatments that extend beyond 16 cycles of the therapy.
Seattle Genetics expects the FDA to make a decision by Sept. 14.
The company said research showed that Adcetris was generally tolerated well by patients taking it for retreatment, and nine of 23 patients who could be evaluated saw complete remission. The drug also was tolerated well when used for an extended duration.
Adcetris is the company's only marketed product, and it already is approved to treat two types of lymphoma.
Seattle Genetics shares climbed more than 2 percent, or 86 cents, to $38.19 in Tuesday morning trading, while broader indexes rose slightly. The stock has climbed more than 60 percent so far this year and hit a 52-week high of $39 last month.