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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 the Treatment of Non-small Cell Lung Cancer, US

    3 days ago · IBTROZI™ (taletrectinib) is a tyrosine kinase inhibitor indicated for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) associated with an abnormal …

  3. Ibtrozi: Uses, Dosage, Side Effects & Warnings - Drugs.com

    Jun 12, 2025 · Ibtrozi is used to treat non-small cell lung cancer (NSCLC) in adults that has spread within the chest or to other parts of the body and is caused by an abnormal ROS1 gene. It is an oral …

  4. 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 …

  5. FDA Approves Ibtrozi for ROS1-Positive Lung Cancer

    Jun 12, 2025 · On June 11, the Food and Drug Administration approved Ibtrozi (taletrectinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). In two …

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

    Jun 12, 2025 · FDA Approves Ibtrozi for ROS1+ NSCLC: Ibtrozi (taletrectinib) has been approved for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), based …

  7. Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study of IBTROZI ...

    Sep 30, 2025 · IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR …

  8. 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 …

  9. 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 …

  10. FDA Approves Taletrectinib for Advanced Non-Small Cell Lung Cancer

    Jun 12, 2025 · The U.S. Food and Drug Administration approved the kinase inhibitor taletrectinib (Ibtrozi) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.