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news.US-based precision oncology biotechnology firm Ignyta has secured orphan drug designation from the US Food and Drug Administration (FDA) for its lead product candidate entrectinib to treat TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC).
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Entrectinib is a new, orally available, selective tyrosine kinase inhibitor and is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK.
The drug has showed in vivo antitumor activity against various TrkA, ROS1 and ALK-driven mouse xenograft models of different human cancers.
Ignyta chairman and CEO Jonathan Lim said: "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.
"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."
Currently, entrectinib is being evaluated in two Phase I/II clinical trials including the STARTRK-1 trial and the ALKA-372-001 trial.