Entrectinib Gains Orphan Drug Status for NTRK Fusion(+) Tumors
Ignyta announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to entrectinib for the treatment of NTRK fusion-positive solid tumors.
Entrectinib is an investigational oral CNS-active tyrosine kinase (TRK) inhibitor designed to target tumors that carry the NTRK1/2/3, ROS1, or ALK gene fusions. It exhibited clinical activity against primary and metastatic central nervous system (CNS) disease and has not shown undesirable off-target activity.
Currently, entrectinib is being evaluated in the global, multicenter, open-label, potentially registration-enabling Phase 2 STARTRK-2 trial (Studies of Tumor Alterations Responsive to Targeting Receptor Kinases).The study incorporates a basket design with screening of tumor samples for the relevant targets. This design enables the potential of entrectinib's clinical activity seen against various tumor types and molecular targets.
The FDA's Orphan Drug designation allows the Company to be eligible for a 7-year period of marketing exclusivity upon approval.
For more information call (858) 255-5959 or visit Ignyta.com.