Dr Bazhenova on the Updated FDA Label for Taletrectinib in ROS1+ NSCLC

On this episode of Targeted Talks, Lyudmila Bazhenova, MD, discusses the FDA’s expanded label approval of taletrectinib (Ibtrozi) for ROS1-positive non–small cell lung cancer (NSCLC). She explains that the approval is based on data already presented at the 2026 AACR Annual Meeting, which showed efficacy in both TKI-naive and TKI-pretreated patients with longer follow-up. In TKI-naive patients, pooled analysis showed an intracranial overall response rate of 76.5%, a median duration of response of 49.7 months, and a median progression-free survival of 46.1 months, with no new safety signals. Bazhenova also reviews 2 new subset analyses from the 2026 World Conference on Lung Cancer: efficacy was similar in patients with and without prior chemotherapy, and it did not differ by ROS1 fusion partner (CD74 vs non-CD74). She shares her approach to managing side effects, including monitoring liver function tests and proactively managing diarrhea, and discusses the ongoing adjuvant trial in resected early-stage ROS1-positive NSCLC.