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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. 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, …

  4. 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 …

  5. Taletrectinib in ROS1+ Non–Small Cell Lung Cancer: TRUST

    Apr 3, 2025 · Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 tyrosine kinase inhibitor (TKI). We report integrated efficacy and safety from registrational …

  6. Ibtrozi Approved for Advanced ROS1-Positive NSCLC

    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 …

  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 (NUVB) Soars on IBTROZI's Blockbuster Launch and …

    1 day ago · Wrap-up: A New Chapter in Targeted Lung Cancer Therapy The success of Nuvation Bio's IBTROZI marks a significant and transformative advancement in the treatment of ROS1 …

  9. 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 …

  10. Taletrectinib for the treatment of ROS-1 positive non-small cell lung

    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 …