Today, precision oncology biotechnology company Ignyta, Inc. announced that its lead candidate has been granted orphan drug designation from US health regulators.
According to the company, the US Food and Drug Administration (FDA) granted Ignyta’s entrectinib orphan drug designation for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC). Orphan drug status provides Ignyta with a seven-year period of market exclusivity, if approved. Additionally, the company will receive tax credit costs for clinical research costs, the ability to apply for annual grant funding, clinical trial assistance and the waiver of Prescription Drug User Fee Act (PDUFA) filing dates.
Entrectinib is a potent, novel, orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors, ROS1 and ALK proteins. The drug is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK. Entrectinib has demonstrated in vivo antitumor activity against various TrkA, ROS1 and ALK-driven mouse xenograft models of different human cancers. The drug is currently in two Phase I/II clinical trials.
“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, MD, Chairman and CEO of Ignyta. “We are pleased to receive from the 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.”
Entrectinib has already received orphan drug designation from the FDA for the treatment of neuroblastoma.
Source: Ignyta, Inc.