Taletrectinib is approved by the USFDA for ROS1-positive non-small cell lung cancer

On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a type of medicine that blocks certain enzymes, for people with advanced or spreading ROS1-positive non-small cell lung cancer (NSCLC).

The effectiveness was evaluated in patients with locally advanced or metastatic, ROS1-positive non-small cell lung cancer (NSCLC) who took part in two large clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811). The efficacy population included 157 patients (103 in TRUST-I and 54 in TRUST-II) who had never received a ROS1 tyrosine kinase inhibitor (TKI) and 113 patients (66 in TRUST-I and 47 in TRUST-II) who had previously received one ROS1 TKI. Patients may have undergone previous treatment for advanced illness.

The main goals for measuring effectiveness were the overall response rate (ORR) and how long the response lasted (DOR), which were evaluated by an independent review team following RECIST v1.1 guidelines. In patients who had not received treatment before, the overall response rate (ORR) was 90% in TRUST-I and 85% in TRUST-II, with 72% and 63% of those who responded having a duration of response (DOR) of at least 12 months, respectively. In patients who had already received TKI treatment, the overall response rate (ORR) was 52% in TRUST-I and 62% in TRUST-II, with 74% and 83% of those who responded having a duration of response (DOR) of six months or more, respectively.

The prescribing information for taletrectinib includes warnings about liver damage, lung disease, heart rhythm changes, high uric acid levels, muscle pain with high creatine phosphokinase, bone fractures, and risks to unborn babies.

The recommended dose of taletrectinib is 600 mg taken by mouth once a day on an empty stomach, meaning no food should be eaten at least 2 hours before and 2 hours after taking it, until the disease gets worse or side effects become too severe.