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# Nuvation Lung Cancer Drug Ibtrozi Approved
- URL: https://www.fdaweb.com/nuvation-lung-cancer-drug-ibtrozi-approved/
- Published: 2025-06-11T12:00:00.000Z
- Updated: 2026-09-14T15:14:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159344

FDA has approved a Nuvation Bio NDA for Ibtrozi (taletrectinib), a kinase inhibitor for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Approval was based on data from two multicenter, single-arm, open-label clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811), an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. The data showed that for treatment-naive patients, the overall response rate (ORR) was 90% in TRUST-I and 85% in TRUST-II, with 72% and 63% of responders having a duration of response greater than 12 months. For tyrosine kinase inhibitor-pretreated patients, ORR was 52% in TRUST-I and 62% in TRUST-II.

“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,” the agency says.