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
RegulatoryapprovedIBTROZIPositive
AI Analysis
Summary
Nuvation Bio announced FDA approval of a supplemental NDA for IBTROZI (taletrectinib) in TKI-naïve advanced ROS1-positive non-small cell lung cancer, with updated labeling reflecting a 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
Primary Endpoint
Met
Outcome Details
FDA approval of supplemental new drug application with updated duration of response data from TRUST-I trial showing nearly 50 months median duration of response; no new safety signals identified
Importance:8/10
Sentiment:
0.90
FDA approvalsupplemental NDAROS1-positive NSCLCduration of responseearly approvalTRUST-I trial
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Published by PR Newswire Pharma on September 17, 2026 11:30 AM