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
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