This article is more than 5 years old. Information may no longer be current.
FDA grants breakthrough therapy designation to entrectinib for NTRK fusion–positive solid tumors
Click Here to Manage Email Alerts
The FDA granted breakthrough therapy designation to entrectinib for the treatment of NTRK fusion–positive locally advanced or metastatic solid tumors, according to the drug’s manufacturer.
The designation applies to use of the agent for adult and pediatric patients who either progressed following prior therapies, or for whom no acceptable standard therapies exist.
Entrectinib (RXDX-101, Ignyta) is a novel, orally available, central nervous system–active tyrosine kinase inhibitor designed to target tumors that harbor activating alterations to NTRK1/2/3, ROS1 or ALK.
The ongoing global, multicenter, open-label phase 2 STARTRK-2 trial is designed to evaluate entrectinib by utilizing a basket design, in which samples from patients with a variety of tumor types are screened for relevant molecular targets.
“The granting of breakthrough therapy designation enables us to continue high-quality engagement with the FDA during the development of entrectinib, and we greatly appreciate the commitment by FDA to move this investigational drug forward,” Jonathan Lim, MD, chairman and CEO of Ignyta, said in a company-issued press release. “We believe this designation validates the broad potential of entrectinib as a novel treatment for patients — regardless of age — with TRK–positive tumors, a group of cancers for which there currently is no approved treatment and which represents a clear unmet medical need.”