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  1. FDA approves taletrectinib for ROS1-positive non-small cell lung cancer

    On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small ...

  2. Ibtrozi for Non-Small-Cell Lung Cancer - WebMD

    Jul 30, 2025 · Ibtrozi is a non-chemotherapy treatment that works by targeting and blocking ROS1 markers on NSCLC cells. How Does Ibtrozi Work for NSCLC?

  3. U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI ...

    Jun 11, 2025 · IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced ROS1-positive …

  4. Taletrectinib Approved for ROS1-Positive NonSmall Cell Lung Cancer

    Jun 13, 2025 · The FDA has granted approval to the kinase inhibitor taletrectinib (Ibtrozi™, Nuvation Bio Inc.) for the treatment of adults with locally advanced or metastatic ROS1-positive non–small cell …

  5. FDA Approves Ibtrozi for ROS1+ Advanced Non-Small Cell Lung Cancer

    Jun 11, 2025 · For patients with ROS1-positive non-small cell lung cancer who had not previously received a tyrosine kinase inhibitor, Ibtrozi was associated with a high rate of disease …

  6. FDA Approves Talectrectinib (Ibtrozi) for ROS1-Positive Lung Cancer

    On June 11, 2025, the U.S. Food and Drug Administration (FDA) approved taletrectinib (Ibtrozi), a new targeted therapy for adults with locally advanced or metastatic ROS1-positive non-small cell lung …

  7. Ibtrozi Approved for Advanced - Cancer Therapy Advisor

    Jun 12, 2025 · The US Food and Drug Administration (FDA) has approved Ibtrozi (taletrectinib) for the treatment of adults with locally advanced or metastatic, ROS1 -positive non-small cell lung cancer …

  8. FDA Approves Nuvation Bio’s Ibtrozi for Locally Advanced or …

    Jun 12, 2025 · The FDA has approved Nuvation Bio’s Ibtrozi (taletrectinib), a next-generation oral ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adults with locally advanced or metastatic ROS1 …

  9. FDA Approves Nuvation Bio’s IBTROZI™ for Advanced ROS1-Positive Lung Cancer

    Jun 11, 2025 · New York, NY — The U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib), a next-generation oral treatment developed by Nuvation Bio, for adults with …

  10. FDA Approves Ibtrozi For Adults With ROS1+ NSCLC

    Jun 12, 2025 · Ibtrozi had a 90% response rate in treatment naïve adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, according to the results of a news release.