On June 11, 2025, the US Food and Drug Administration (FDA) announced the approval of taletrectinib (Ibtrozi™) to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ROS1 rearrangements.
Taletrectinib is a next-generation, highly specific kinase inhibitor of ROS1 that was designed to treat ROS1+ NSCLC in patients whose tumors have developed drug resistance to previous targeted therapies as well as a first treatment option for newly diagnosed patients.
The FDA approval is supported by data from two phase 2 clinical trials: TRUST-I and TRUST-II. Both studies included a mix of:
- Previously untreated patients
- Patients whose tumors had been treated with a ROS1 TKI (tyrosine kinase inhibitor) and then developed drug resistance and began to grow again
For patients without previous treatment, the cancer shrank or disappeared with taletrectinib treatment (overall response rate) in 90% of patients enrolled in TRUST-I and 85% of patients enrolled in TRUST-II.
For patients who had previously been treated with a TKI, the cancer shrank or disappeared with taletrectinib treatment in 52% of patients in TRUST-I and 62% of patients in TRUST-II.
For more details, including common side effects, please see this information from the FDA announcing the drug approval.
Learn more about taletrectrinib from an expert in the field.
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