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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. Ibtrozi: Uses, Dosage, Side Effects & Warnings - Drugs.com

    Jun 12, 2025 · Ibtrozi is used to treat non-small cell lung cancer (NSCLC) in adults that has spread within the chest or to other parts of the body and is caused by an abnormal ROS1 …

  3. IBTROZI™ (Taletrectinib), FDA-Approved Treatment, Available at ...

    Cary, N.C. , June 11, 2025 – Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas, has been selected by Nuvation Bio as a …

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

    Jun 11, 2025 · IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced …

  5. 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). …

  6. 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 …

  7. 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 …

  8. 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).

  9. 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 …

  10. Taletrectinib Approved for ROS1-Positive NSCLC | AJMC

    Jun 11, 2025 · US Food and Drug Administration approved Nuvation Bio’s Ibtrozi (taletrectinib), a next-generation oral treatment for advanced ROS-1 positive non–small cell lung cancer. June …