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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, …

  3. Taletrectinib's Sustained Efficacy in Advanced ROS1-Positive NSCLC

    Sep 8, 2025 · Updated results from the pivotal phase 2 TRUST-II study of taletrectinib (Ibtrozi) in adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung …

  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, …

  5. Taletrectinib Recommended in NCCN Guidelines for ROS1

    Jul 31, 2025 · Taletrectinib (Ibtrozi; Nuvation Bio) was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Non-Small Cell Lung …

  6. 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 …

  7. FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive …

    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 …

  8. 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 …

  9. NCCN Guidelines Now Recommend Taletrectinib for ROS1+ NSCLC

    Jun 25, 2025 · The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancers (NSCLC) have added taletrectinib (Ibtrozi) as a …

  10. 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 …