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
The FDA accepted Nuvation Bio's supplemental NDA for IBTROZI with a target action date of January 4, 2027. The submission includes updated data showing a median duration of response of 49.7 months and median progression-free survival of 49.6 months in TKI-naïve patients.
Key figures
- Tki naive mdor months
- 49.7
- Tki naive mpfs months
- 49.6
- Tki pretreated mdor months
- 19.4
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