On February 17, 2015 Ignyta, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Ignyta’s lead product candidate entrectinib for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer (Press release Ignyta, FEB 17, 2015, View Source [SID:1234501634]).

“We are pleased to receive from the FDA this orphan drug designation for colorectal cancer, our third orphan designation in addition to neuroblastoma and non-small cell lung cancer,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “Entrectinib has the potential to address unmet needs of patients with rare cancers, and we will continue to aggressively pursue our clinical development program for entrectinib in solid tumors for the benefit of these patients and to create value for our stockholders.”