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Clinical data | |
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Trade names | Ibtrozi |
AHFS/Drugs.com | Ibtrozi |
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Routes of administration | By mouth |
Drug class | Antineoplastic |
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Chemical and physical data | |
Formula | C23H24FN5O |
Molar mass | 405.477 g·mol−1 |
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Taletrectinib, sold under the brand name Ibtrozi, is an anti-cancer medication used for the treatment of non-small cell lung cancer. [1] [2] It is used as the salt, taletrectinib adipate. [1] Taletrectinib is a kinase inhibitor. [1] It is taken by mouth. [1]
Taletrectinib was approved for medical use in the United States in June 2025. [3]
Taletrectinib is indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. [1] [2]
The FDA prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. [1] [3]
The efficacy of taletrectinib to treat ROS1-positive non-small cell lung cancer was evaluated in participants with locally advanced or metastatic, ROS1-positive non-small cell lung cancer enrolled in two multi-center, single-arm, open-label clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811). [3] The efficacy population included 157 participants (103 in TRUST-I; 54 in TRUST-II) who were naïve to treatment with a ROS1 tyrosine kinase inhibitor (TKI) and 113 participants (66 in TRUST-I; 47 in TRUST-II) who had received one prior ROS1 tyrosine kinase inhibitor. [3] Participants may have received prior chemotherapy for advanced disease. [3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review, breakthrough therapy, and orphan drug designations. [3]
Taletrectinib was approved for medical use in the United States in June 2025. [3] [4]
Taletrectinib is the international nonproprietary name. [5]