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Ignyta Receives FDA Orphan Drug Designation for Entrectinib for Treatment of NTRK Fusion-Positive Solid Tumors

SAN DIEGO--(BUSINESS WIRE)--Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to entrectinib for “treatment of NTRK fusion-positive solid tumors.” NTRK fusions are molecular alterations that occur in a broad variety of adult and pediatric solid tumor types. Entrectinib is the company’s investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions.

About Orphan Drug Designation

Under the FDA’s Orphan Drug Designation program, orphan drug designation is granted by the FDA to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation allows the drug developer to be eligible for a seven-year period of U.S. marketing exclusivity upon approval of the drug, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical trial design assistance, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About Entrectinib

Entrectinib is a novel, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TRKA/TRKB/TRKC), ROS1 or ALK. Entrectinib is the only TRK inhibitor with clinically demonstrated activity against primary and metastatic CNS disease, and has not shown undesirable off-target activity. This product candidate is in a Phase 2 clinical trial called STARTRK-2, which is the second of the “Studies of Tumor Alterations Responsive to Targeting Receptor Kinases.” The...


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