Entrectinib Designated Orphan Drug for NSCLC

Ignyta announced that the Food and Drug Administation (FDA) has granted Orphan Drug designation to entrectinib for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC).

Entrectinib is an orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins. Entrectinib is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK.

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Entrectinib is currently being evaluated in two Phase 1/2 clinical trials, the STARTRK-1 trial and the ALKA-372-001 trial. Interim results were presented from the ALKA-372-001 study in September 2014. The interim findings demonstrated that eight patients remained on active treatment across the three dosing schedules, with four patients having received nine to 21 cycles of treatment. A complete response was achieved in one patient with ROS1-positive NSCLC. Five patients with three different cancer histologies (colorectal cancer, NSCLC and neuroblastoma) and in patients with each of TrkA, ROS1 and ALK alterations demonstrated partial responses. Entrectinib demonstrated prolonged stable disease in two patients: one with ALK-positive NSCLC and one with ROS1-positive pancreatic cancer.

The FDA previously had granted Orphan Drug designation to entrectinib for the treatment of neuroblastoma.

For more information visit Ignyta.com.