Posted by Michael Wonder on 08 May 2026
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
6 May 2026 - Application includes updated TRUST-I TKI naïve median duration of response and median progression-free survival of more than 4 years, as well as TRUST-II TKI pretreated mDOR of nearly 20 months.
Nuvation Bio announced today that the US FDA has accepted a supplemental new drug application with updated data for Ibtrozi (taletrectinib) in both TKI naïve and TKI pretreated advanced ROS1 positive non-small-cell lung cancer with a target action date of 4 January 2027.
