Nuvation Lung Cancer Drug Ibtrozi Approved

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 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.