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

    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. ROS1+ NSCLC Therapy | IBTROZI™ (taletrectinib)

    INDICATION IBTROZI ™ (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).

  4. 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 …

  5. FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive Non ...

    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 non-small cell lung …

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

    Jun 11, 2025 · The U.S. Food and Drug Administration had approved Ibtrozi (taletrectinib) for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The …

  8. 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 …

  9. 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 …

  10. Taletrectinib Approved for ROS1-Positive NSCLC | AJMC

    Jun 11, 2025 · Today’s approval of taletrectinib (Ibtrozi; Nuvation Bio Inc) by the FDA for ROS1-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) comes on the heels of the …