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| Trade names | Ibtrozi |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a625089 |
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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 nameIbtrozi, is ananti-cancer medication used for the treatment ofnon-small cell lung cancer.[1][2] It is used as the salt, taletrectinib adipate.[1] Taletrectinib is akinase inhibitor.[1] It is takenby mouth.[1]
Taletrectinib was approved for medical use in the United States in June 2025.[3][4]
Taletrectinib isindicated for the treatment of adults with locally advanced or metastaticROS1-positivenon-small cell lung cancer.[1][4]
The USFood and Drug Administration (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 USFood and Drug Administration (FDA) approved taletrectinib based on evidence from 270 participants withROS1-positive NSCLC that had spread beyond the lungs who received taletrectinib 600 mg orally once daily, enrolled in two clinical trials: TRUST-I (NCT04395677) or TRUST-II (NCT04919811).[4] The TRUST-I trial was conducted exclusively in China and the TRUST-II trial was conducted globally in North America (United States and Canada), Europe (France, Italy, Spain, and Poland), and Asia (China, Japan, and South Korea).[4]
The efficacy of taletrectinib to treatROS1-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 safety of taletrectinib was evaluated in 352 participants (337 with non-small cell lung cancer and 15 with other solid tumors) who received at least one 600 mg dose of taletrectinib.[4] In the 337 participants with non-small cell lung cancer, the median age was 56 years (range: 26 to 83); 56% female; 76% Asian, 15% White, 0.6% Black or African American, 8% unknown or other races; and 1.8% were of Hispanic or Latino ethnicity.[4] The number of participants representing efficacy findings differs from the number of participants representing safety findings due to different groups of study participants analyzed for efficacy and safety.[4]
The FDA granted the application for taletrectinibpriority review,breakthrough therapy, andorphan drug designations.[3]
Taletrectinib was approved for medical use in the United States in June 2025.[3][5]
Taletrectinib is theinternational nonproprietary name.[6]
Taletrectinib is sold under the brand name Ibtrozi.[3][5]
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