Posted by Michael Wonder on 16 May 2017
Ignyta granted breakthrough therapy designation for entrectinib by U.S. Food and Drug Administration
15 May 2017 - Ignyta today announced that the U.S. FDA has granted a breakthrough therapy designation to entrectinib for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies.
Entrectinib is the company's investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumours that harbour NTRK1/2/3, ROS1, or ALK gene fusions.
