Rozlytrek Approval History
FDA Approved: Yes (First approved August 15, 2019)
Brand name: Rozlytrek
Generic name: entrectinib
Dosage form: Capsules
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.
Development History and FDA Approval Process for Rozlytrek
|Aug 15, 2019|| FDA Approves Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors|
|Feb 18, 2019||FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib|
|Oct 21, 2018||Genentech’s Investigational Personalized Medicine Entrectinib Shrank Tumors in People With NTRK Fusion-Positive Solid Tumors|
|Sep 24, 2018||Genentech’s Investigational Medicine Entrectinib Showed a Durable Response of More Than Two Years in People With a Specific Type of Lung Cancer|
|Jul 10, 2017||Ignyta Receives FDA Orphan Drug Designation for Entrectinib for Treatment of NTRK Fusion-Positive Solid Tumors|
|May 15, 2017||Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration|
|Apr 17, 2016||Ignyta Announces Updated Data from Entrectinib Phase 1 Clinical Trials at the 2016 AACR Annual Meeting|
|Jul 6, 2015||Ignyta Announces Collaboration with UCSF For Clinical Trial of Entrectinib|
|Dec 29, 2014||Ignyta Receives Orphan Drug Designation and Rare Pediatric Disease Designation for Entrectinib|
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