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Trade names | Augtyro |
Other names | TPX-0005 |
AHFS/ Drugs.com | Augtyro |
License data | |
Routes of administration | By mouth |
Drug class | Tyrosine kinase inhibitor |
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Chemical and physical data | |
Formula | C18H18FN5O2 |
Molar mass | 355.373 g·mol−1 |
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Repotrectinib, sold under the brand name Augtyro, is an anti-cancer medication used for the treatment of non-small cell lung cancer. [1] [2] It is taken by mouth. [1] Repotrectinib is an inhibitor of proto-oncogene tyrosine-protein kinase ROS1 (ROS1) and of the tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB, and TRKC. [1]
The most common adverse reactions include dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, ataxia, fatigue, cognitive disorders, and muscular weakness. [2]
Repotrectinib was approved for medical use in the United States in November 2023. [2] [3]
Repotrectinib is indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. [1] [2]
Approval by the US Food and Drug Administration (FDA) was based on TRIDENT-1, a global, multicenter, single-arm, open-label, multi-cohort clinical trial (NCT03093116) which included participants with ROS1-positive locally advanced or metastatic non-small cell lung cancer. [2] Efficacy was evaluated in 71 ROS1 tyrosine kinase inhibitor-naïve participants who received up to one prior line of platinum-based chemotherapy and/or immunotherapy and 56 participants who received one prior ROS1 tyrosine kinase inhibitor with no prior platinum-based chemotherapy or immunotherapy. [2]
The FDA granted the application for repotrectinib priority review, breakthrough therapy, and fast track designations. [2]