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FDA approves updated label for IBTROZI with nearly 50 months median response in ROS1+ NSCLC patients

Market News
17 Sep 2026
PRNewsWire
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Bullish
FDA approves updated label for IBTROZI with nearly 50 months median response in ROS1+ NSCLC patients

The FDA has approved an updated label for IBTROZI (taletrectinib), a treatment for ROS1-positive non-small cell lung cancer (NSCLC), reflecting a median duration of response of nearly 50 months in TKI-naïve patients from the TRUST-I study. This update confirms long-term clinical benefit and safety with no new safety concerns after extended follow-up. The approval, granted four months ahead of schedule, reinforces IBTROZI as a durable and tolerable treatment option for advanced ROS1+ NSCLC. Nuvation Bio continues to advance global regulatory efforts and ongoing clinical trials for this therapy.

The FDA approval update for IBTROZI® highlights a median duration of response of nearly 50 months in TKI-naïve advanced ROS1-positive non-small cell lung cancer patients. For readers following the health sector, here is Pluang's market snapshot as of Sep 17, 2026 18:11 WIB: out of 91 priced US health stocks, 63 rose and 25 fell. Notable movers include Sana Biotechnology Inc (SANA) at USD 3.00 with 86% sell order activity, Twist Bioscience Corp (TWST) at USD 146.86 with nearly balanced buy/sell activity, and BioNano Genomics Inc (BNGO) at USD 1.55 with 77% sell order activity.

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