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FDA approves Ibtrozi label update with 49.7-month DOR in ROS1 NSCLC
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Fusion42 · 18 September 2026 · Fusion42 review
The US FDA has approved an updated label for Nuvation Bio's Ibtrozi (taletrectinib) showing a median duration of response of 49.7 months in tyrosine kinase inhibitor-naïve patients with ROS1-positive non-small cell lung cancer, reflecting longer follow-up data and no new safety concerns.
This Wire brief sits within Fusion42's coverage of Biotech, and 6 sources have reported it between 17 Sep 2026 and 18 Sep 2026.
◆ ◆ The Wire takeaway
You can present longer-term efficacy data for ROS1 inhibitors confidently as the FDA has validated taletrectinib's durability. Your development strategies for lung cancer treatments now face a higher benchmark for duration of response.
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6 sources · first reported 17 Sep 2026 · latest 18 Sep 2026
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