Ignyta announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to entrectinib for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer. Entrectinib is a potent, orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins.
Entrectinib is currently in two Phase 1/2 clinical trials, the STARTRK-1 trial and the ALKA-372-001 trial. Interim results from the ALKA-372-001 study were presented in September 2014. The interim findings showed that eight patients remained on active treatment across the three dosing schedules, with four patients having received 9–21 cycles of treatment. Entrectinib demonstrated a complete response in a patient with ROS1-positive non-small cell lung cancer (NSCLC). Entrectinib demonstrated five partial responses, in patients with three different cancer histologies (colorectal cancer, NSCLC and neuroblastoma) and in patients with each of TrkA, ROS1 and ALK alterations. Entrectinib demonstrated prolonged stable disease in two patients: one with ALK-positive NSCLC and one with ROS1-positive pancreatic cancer.
Previously the FDA had granted Orphan Drug designation to entrectinib for the treatment of neuroblastoma and NSCLC.
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