IBTROZI (taletrectinib)
Advanced ROS1-positive non-small cell lung cancer — updated response and duration-of-response data · Adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, including TKI-naïve and TKI-pretreated patients
NUVB · Nuvation Bio
完整時間線
3 個里程碑FDA approved the sNDA ahead of the PDUFA date
FDA approved the label supplement to add updated TRUST-I and TRUST-II response and duration-of-response data; the approval letter records the action as effective on September 16, 2026.
FDA — IBTROZI sNDA approval letter↗Original PDUFA target action date
FDA had assigned January 4, 2027 as the target action date for the sNDA, which was submitted to fulfill a postmarketing commitment.
Nuvation Bio — sNDA acceptance and target action date↗FDA accepted the sNDA for review
The supplement included an additional 10 months of TRUST-I and TRUST-II follow-up, with 49.7 months’ median duration of response in TKI-naïve TRUST-I patients and 19.4 months in TKI-pretreated TRUST-II patients.
Nuvation Bio — updated TRUST data and sNDA acceptance↗相關新聞
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