Nuvation Bio Reports US FDA Approval of Ibtrozi for ROS1+ NSCLC

Shots: The US FDA has approved an sNDA for Ibtrozi (taletrectinib) for the treatment of locally advanced or metastatic ROS1-positive NSCLC, 4mos. ahead of its PDUFA target action date Updated Ibtrozi label reports a mDoR of 49.7mos. in TKI-naïve TRUST-I pts, with no new safety signals; based on 51mos. of mFU & an additional 14mos. of P-II (TRUST-I & II) data through Aug 2025, the results demonstrate durable responses & tolerability Additionally, Nuvation Bio & Eisai reported that Ibtrozi’s MAA was validated by the EMA in Mar 2026 for full approval consideration under a standard review timeline, followed by MAA validation by the UK MHRA in Jun 2026 Ref: PRnewswire |  Image: Nuvation Bio  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Nuvation Bio Reports US FDA Approval of Ibtrozi for ROS1+ NSCLC appeared first on PharmaShots.