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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. FDA OKs New Next-Gen Pill for Rare Lung Cancer - WebMD

    Jun 12, 2025 · The FDA has approved an oral pill called taletrectinib (Ibtrozi) to treat people who have a rare type of non-small-cell lung cancer (NSCLC) that is linked to a faulty ROS1 gene and has spread …

  3. 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 …

  4. 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 …

  5. 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 …

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

    About Ibtrozi 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 …

  7. 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 …

  8. FDA clears Nuvation lung cancer drug, setting up battle with Bristol ...

    Jun 11, 2025 · FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche The drug, Ibtrozi, will now vie for market share in an indication where multiple large pharmaceutical …

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

    Jun 11, 2025 · IBTROZI is a highly selective ROS1 tyrosine kinase inhibitor (TKI) designed to address key challenges in treating ROS1-positive NSCLC, a rare and aggressive cancer type affecting about …

  10. Taletrectinib Gains FDA Approval for Locally Advanced or Metastatic ...

    Jun 11, 2025 · The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer …