Seattle Genetics drug gets new orphan drug review
BOTHELL, Wash. (AP) — Seattle Genetics Inc. said Monday the Food and Drug Administration awarded orphan drug status to its lymphoma drug Adcetris as it seeks a broader marketing approval.
Adcetris is approved as a treatment for two types of lymphoma, and the company wants to get approval to market the drug as a treatment for mycosis fungoides, the most common type of cutaneous T-cell lymphoma.
Seattle Genetics said the drug has received orphan drug status in that indication, which means that if Adcetris is approved as a treatment for that disease, the FDA won't approve similar products for seven years.
Orphan drug status is given to treatments for disease that affect fewer than 200,000 Americans.
Adcetris is Seattle Genetics' only marketed product. Shares of Seattle Genetics fell 14 cents to $25.38 in midday trading.