Nuvation Bio gets FDA approval for IBTROZI® label update
FDA approved Nuvation Bio’s supplemental new drug application for IBTROZI® (taletrectinib), updating TRUST-I data to reflect a nearly 50-month median duration of response in TKI-naïve advanced ROS1-positive non-small cell lung cancer.
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11:31:25 AM UTC
SquawkNews
Nuvation Bio said the FDA approved an sNDA for IBTROZI (taletrectinib), adding a 49.7-month median DOR in TKI—naïve ROS1+ NSCLC from TRUST—I, with no safety label changes. Approval came about four months ahead of the PDUFA date.Material DetailsContext by AI AnalystThis is a late-stage validation up…
7-month median DOR in TKI-naïve ROS1+ NSCLC from TRUST-I, with no safety label changes. The approval came about four months ahead of the PDUFA date.