Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer
RegulatoryapprovedIBTROZI®Positive
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Summary
Nuvation Bio announced FDA approval of a supplemental new drug application for IBTROZI (taletrectinib) in TKI-naïve advanced ROS1-positive non-small cell lung cancer, reflecting an updated median duration of response of nearly 50 months from the TRUST-I trial. The approval came four months ahead of the PDUFA date with no new safety signals identified.
Clinical Trial Data
Outcome Details
FDA approval of supplemental new drug application with updated duration of response of nearly 50 months from TRUST-I trial; no new safety signals identified
Importance:9/10
Sentiment:
0.90
FDA approvalsupplemental NDAROS1-positive NSCLCduration of responseaccelerated timeline
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Published by PR Newswire Biotech on September 17, 2026 11:30 AM