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

    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. Nuvation Bio Inc. - U.S. Food and Drug Administration ...

    Jun 11, 2025 · NEW YORK-- (BUSINESS WIRE)-- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced …

  3. FDA Approves Taletrectinib for ROS1-Positive NSCLC Treatment

    Jun 13, 2025 · FDA approval of Taletrectinib for ROS1 positive Non Small Cell Lung Cancer Taletrectinib was approved by the U.S. Food and Drug Administration (FDA) on June 11, 2025, for …

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

    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 …

  5. Taletrectinib Increases Already Broad Selection of ROS1 ...

    On June 11, 2025, the FDA approved taletrectinib (Ibtrozi) for the treatment of patients with locally advanced or metastatic ROS1 -positive non–small cell lung cancer (NSCLC). 1 In the wake of this …

  6. NCCN Adds Taletrectinib to ROS1+ NSCLC Recommendations

    Jun 26, 2025 · The NCCN has added taletrectinib to its recommendations for use in all lines of treatments for non–small cell lung cancer harboring ROS1 mutations. The National Comprehensive …

  7. Taletrectinib for the treatment of ROS-1 positive non-small ...

    Abstract Introduction: While crizotinib and entrectinib have been approved to treat ROS1 fusion-positive (ROS1+) non-small-cell lung cancer (NSCLC), unmet needs remain. These unmet needs include …

  8. Taletrectinib Approved for ROS1-Positive Non–Small Cell Lung ...

    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 …

  9. 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 …

  10. FDA Approves Nuvation Bio’s IBTROZI™ (taletrectinib), a Next ...

    Jul 2, 2025 · Nuvation Bio Inc., a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced on June 11 that the U.S. Food and Drug Administration …