Ignyta Gets Orphan Drug Designation From FDA For Entrectinib - Quick Facts

(RTTNews) - The U.S. Food and Drug Administration or FDA has granted orphan drug designation for Ignyta, Inc.'s (RXDX) lead product candidate entrectinib for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer.

Jonathan Lim, M.D., Chairman and CEO of Ignyta, noted, "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."

Entrectinib is a potent, novel, orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins. Currently, Entrectinib is in two Phase I/II clinical trials, the STARTRK-1 trial and the ALKA-372-001 trial.

Earlier, Ignyta said that the FDA had granted orphan drug designation for entrectinib for the treatment of neuroblastoma and NSCLC.