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Ignyta's (RXDX) Entrectinib Granted FDA Orphan Drug Designation

February 5, 2015 9:17 AM EST

Ignyta (NASDAQ: RXDX) announced 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 and ALK-positive non-small cell lung cancer (NSCLC).

“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,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “We are pleased to receive from FDA this second orphan drug designation for non-small cell lung cancer, in addition to neuroblastoma, which can potentially provide additional avenues for creating value for our stockholders through our entrectinib clinical program.”



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