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FDA Grants Entrectinib Breakthrough Designation for NTRK+ Solid Tumors

Published: Tuesday, May 16, 2017

Dr. Jonathan Lim

Jonathan Lim, MD

The FDA has granted a breakthrough therapy designation to entrectinib for use as a treatment for adult and pediatric patients with NTRK-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or who have no acceptable standard therapies, according to Ignyta, the manufacturer of the multikinase inhibitor.

 rearrangements.
Drilon A, De Braud FG, Siena S, et al. Entrectinib, an oral pan-Trk, ROS1, and ALK inhibitor in TKI-naïve patients with advanced solid tumors harboring gene rearrangements. Presented at the 2016 AACR Annual Meeting; April 16-20, New Orleans, Louisiana. Abstract CT007.

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