On June 11, 2025, officials with the FDA approved taletrectinib (Ibtrozi; Nuvation Bio), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC).1
Efficacy was evaluated in patients with locally advanced or metastatic ROS1-positive NSCLC enrolled in 2 multicenter, single-arm, open-label clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811). The efficacy population included 157 patients (103 in TRUST-I; 54 in TRUST-II) who were naïve to treatment with a ROS1 tyrosine kinase inhibitor (TKI) and 113 patients (66 in TRUST-I; 47 in TRUST-II) who had received one prior ROS1 TKI. Patients may have received prior chemotherapy for advanced disease.
For treatment-naive patients, the overall response rate (ORR) was 90% (95% confidence interval [CI], 83-95) in TRUST-I and 85% (95% CI, 73-93) in TRUST-II, with 72% and 63% of responders having a duration of response (DOR) ≥12 months, respectively. For TKI-pretreated patients, ORR was 52% (95% CI, 39-64) in TRUST-I and 62% (95% CI, 46-75) in TRUST-II, with 74% and 83% of responders having a DOR ≥6 months, respectively.
The 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.
Reference
- FDA. FDA approves taletrectinib for ROS1-positive non-small cell lung cancer [press release]. June 12, 2025. Accessed July 1, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer