Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer
The FDA approved a supplemental New Drug Application for Nuvation Bio's IBTROZI (taletrectinib), updating the label with a nearly 50-month median duration of response in TKI-naïve advanced ROS1-positive non-small cell lung cancer. Approval came about four months ahead of the PDUFA date, with no changes to safety labeling and no new safety signals identified.
Why it matters — The early FDA approval and updated efficacy data strengthen the commercial standing of Nuvation Bio's lead drug IBTROZI in the ROS1-positive NSCLC market.