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Rozlytrek FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 25, 2023.

FDA Approved: Yes (First approved August 15, 2019)
Brand name: Rozlytrek
Generic name: entrectinib
Dosage form: Capsules and Oral Pellets
Company: Genentech, Inc.
Treatment for: Solid Tumors, Non Small Cell Lung Cancer

Rozlytrek (entrectinib) is a selective tyrosine kinase inhibitor for the treatment of patients with ROS1-positive, metastatic non-small cell lung cancer and neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumors.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Development timeline for Rozlytrek

Oct 20, 2023Approval FDA Expands Pediatric Indication for Rozlytrek (entrectinib) and Approves New Pellet Formulation
Aug 15, 2019Approval FDA Approves Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors
Feb 18, 2019FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib
Oct 21, 2018Genentech’s Investigational Personalized Medicine Entrectinib Shrank Tumors in People With NTRK Fusion-Positive Solid Tumors
Sep 24, 2018Genentech’s Investigational Medicine Entrectinib Showed a Durable Response of More Than Two Years in People With a Specific Type of Lung Cancer
Jul 10, 2017Ignyta Receives FDA Orphan Drug Designation for Entrectinib for Treatment of NTRK Fusion-Positive Solid Tumors
May 15, 2017Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration
Jul  6, 2015Ignyta Announces Collaboration with UCSF For Clinical Trial of Entrectinib
Dec 29, 2014Ignyta Receives Orphan Drug Designation and Rare Pediatric Disease Designation for Entrectinib

Further information

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