PR Newswire Clinical TrialsOriginal article
Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in Advanced ROS1-Positive Non-Small Cell Lung Cancer
NDA FilingIBTROZIPositive
AI Analysis
Summary
Nuvation Bio announced FDA acceptance of a supplemental new drug application for IBTROZI (taletrectinib) with updated duration of response and progression-free survival data from trials in ROS1-positive non-small cell lung cancer. The FDA assigned a target action date of January 4, 2027.
Clinical Trial Data
Primary Endpoint
Met
Outcome Details
FDA accepted supplemental new drug application with updated efficacy data from TRUST-I (TKI-naïve) and TRUST-II (TKI-pretreated) trials
Importance:7/10
Sentiment:
0.70
FDA_AcceptancesNDAOncologyROS1_MutationNSCLCEfficacy_Data
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Published by PR Newswire Clinical Trials on May 6, 2026 12:00 PM