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

    Jun 16, 2025 · FDA Approves Talectrectinib (Ibtrozi) for ROS1-Positive Lung Cancer For patients with ROS1-positive NSCLC, especially those who have exhausted other options or have brain …

  4. 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 …

  5. Lung Cancer Novel Agents in Metastatic NSCLC

    Dec 13, 2025 · Lung cancer affects more than 200,000 people in the United States annually; non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases. 1-3 Lung cancer …

  6. 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 …

  7. Taletrectinib Approved for ROS1-Positive NSCLC | AJMC

    Jun 11, 2025 · US Food and Drug Administration approved Nuvation Bio’s Ibtrozi (taletrectinib), a next-generation oral treatment for advanced ROS-1 positive non–small cell lung cancer. June 11, 2025.

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

    Jun 11, 2025 · Serious side effects were rare, and treatment discontinuation due to adverse events occurred in just 7% of patients. Nathan Pennell, M.D., Ph.D., a study investigator and lung cancer …

  9. Taletrectinib Approved for ROS1-Positive Non–Small 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 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 …